Correspondence to Yuexian Tao; [email protected]
STRENGTHS AND LIMITATIONS OF THIS STUDY
This is a goal-oriented theoretical framework based on a physical activity facilitation intervention for emerging adults using a hybrid face-to-face and e-health approach to provide personalised support to improve self-perception and motivation to exercise.
A further distinguishing feature is the involvement of the client in the joint development of the physical activity promotion programme (including the setting of goals and the means to achieve them).
Implementing web-based and face-to-face interventions that provide additional social and peer support for emerging adults in college can improve adherence and reduce dropout rates.
The limitation is the single-centre design, which involves a limited number of clients and health managers.
The study sample may not be fully representative of the large scale population, which could limit the generalisability of findings.
Introduction
Physical inactivity threatens public health and health economics. Over 80% of adolescents and 27% of adults failed the physical activity (PA) requirements of WHO.1 A China Health and Nutrition Survey (CHNS) found that less than 25% of Chinese individuals exercise weekly.2 Physical inactivity costed 53.8 billion international dollars (INT$) in worldwide health systems in 20133 and might cost INT$520 billion over 11 years (2020–2030).4
Emerging adulthood (EA) is a stage of autonomous life after adolescence but before full adulthood, with a focus on the age range of 18–25.5 Most people in this period are studying at universities and have not yet fully entered the responsible adult world, compared with other social groups.6 Studies have shown that the transition from adolescence to adulthood is a critical period for weight gain and increases the risk of unhealthy diet and physical inactivity.7 8 The results of one study showed that the majority of emerging adults were classified as low moderate to vigorous physical activity (51.2%).9 Data from the EAT (Eating and Activity over Time) 2010–2018 Project of USA showed that the prevalence of food insecurity among emerging adults was 23.3%.10
Encouraging PA can be an effective response to this public challenge, and physical activity early in life may have greater health benefits. Early PA is closely related to later somatic and cognitive functions. One study found that high levels of PA in early adulthood tended to be associated with a lower risk of stress urinary incontinence in middle-aged women.11 In addition, studies have shown that any level of PA in adulthood contributes to maintaining cognitive health in later life.12 Possible mechanisms for this include the effects of physical inactivity on poorer sleep quality.13 Poor sleep, in turn, impairs cognitive functions such as memory, attention and executive functions.14
Also, most studies focus on body weight and weight loss rather than maintaining a balanced body composition. Body composition is associated with an increased risk of chronic metabolic and cardiovascular disease, representing important potential outcomes of PA interventions.15 Body composition and percentage of body fat can predict health risks better than just classifying obesity using body mass index (BMI), as they can provide a clearer picture of health risk, especially if someone falls into the overweight or obese group in terms of BMI.16
Some studies using technology-based counselling or other new treatment techniques have focused specifically on weight loss in emerging adults, but these strategies for motivating people to adopt and sustain healthy behaviours are suboptimal. In a randomised experiment, text messages improved motivation in 188 overweight and obese young adults, but BMI did not alter.17 LaRose et al. in a university medical centre in Virginia, examined two theory-based motivational spurts for weight loss among emerging adults and found partial effects but no significant changes.18
Humans exhibit different physiological and psychological developmental characteristics at different stages of growth, which have an important impact on the demand for PA.19 EA is a special phase of human development from adolescence to adulthood. Therefore, it is necessary to properly consider the physiological and psychological characteristics at this specific stage to ensure the effectiveness of PA intervention programmes.
Common motivational strategies applied in lifestyle modification coaching or structured educational programmes include individual assessment of risk factor,20 counselling and monitoring of lifestyle goals,21 negotiating an action plan to achieve personal goals and providing feedback22 and emotional support and coping guidelines for lifestyle changes.23 Active engagement of emerging adults in goal discussions and early nursing processes is a key strategy to optimise management outcomes.24 The level of emerging adults’ initial perception and self-control of current lifestyles can be important determinants of their motivation formation and subsequent adoption of a healthy lifestyle. Programmes that manage and change health habits simply based on the status quo have a limited chance of success if participants are unwilling to embrace new behaviours and their needs are not addressed in management plans.
Based on the goal attainment theory, the current study used a goal-directed educational programme for emerging adults to assess the programme’s impact on body composition, PA and self-efficacy over a 4-month period. The client and nurse must collaborate to create goals and work towards those goals, according to King’s goal attainment theory.25 Targeted strategies based on the King’s framework can be applied to emerging adults to ensure effective behaviour change through an interaction process in which the young adult and the healthcare professional mutually identify individual specific metabolic risks and agree to pursue the goal of risk management together.
PA interventions in EA with physical inactivity will reduce both the lifetime burden of disease and cardiometabolic risk. To accomplish this, this research will adapt behavioural weight management to meet the practical, psychological and developmental needs of emerging adults. This study therefore aims to evaluate the effectiveness of the blended face-to-face and e-health interventions PA promotion programme for emerging adults with physical inactivity based on goal attainment theory.
Methods
Study setting and design
This is a 16-week, prospective, double-blind, two-arm, randomised controlled trial. The purpose of this study is to examine the effectiveness of goal attainment theory-based PA promotion on anthropometric outcomes in emerging adults with physical inactivity. This study will be conducted on 28 April 2023 at the Rehabilitation Nursing Laboratory in the corresponding author’s affiliated institute in China. Ethical guidelines approved by Medical Ethics Committee of the institute are followed (ratification date: 14 November 2022, 2022059). This report follows the guidelines of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist26 and the SPIRIT Outcomes 2022 Extension.27 The SPIRIT checklist can be found in online supplemental file 1. The study design is shown in figure 1.
Figure 1. SPIRIT participants’ flow and assessments.CG, control group; GAT-Pap, goal achievement theory-based physical activity; MET, metabolic equivalent; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.
Eligibility
Participants are considered eligible if they meet all of the inclusion criteria and none of the exclusion criteria.
Inclusion criteria
Emerging adults (aged 18–25 years).
Physical inactivity (weekly PA<600 MET-min/w; MET, metabolic equivalent).
Exclusion criteria
Those people who have taken medication in the past 3 months will be excluded from the study because some medications may interfere with the impact of the intervention on outcomes.
Dietary restrictions could affect the anthropometric results. Therefore, those who require special dietary adjustments due to food allergies, coeliac disease or lactose intolerance are also excluded.
Pregnancy occurring now or expected within the next 6 months is ruled out as it may affect PA levels and body composition.
Sample size
The sample size is calculated based on similar previous studies. A domestic intervention study28 reports a reduction in body fat from 31.17% to 28.38%.29 We therefore assume that the response after 16 weeks of follow-up will be stronger than in the previous study. Therefore, based on the previous study and power calculations, the study is designed to detect a 5% difference in body fat percentage between the intervention and control groups. In addition, a local epidemiological study of 20 to 30-year-olds in Hangzhou revealed a mean body fat percentage of 25.58% with a SD of 8.5.30 This SD value of 8.5 was used in the sample size calculation to detect a 5% difference in body fat percentage between the intervention and control groups with a power of 80% and a significance level of 0.05. The Power and Sample Size (PASS) Software 2022 was used to calculate sample size (alternative hypothesis: two-sided, β=0.80, α=0.05, group allocation: equal (n1=n2), mean difference: d=5.00, SD: s=8.5). An approximate total sample size of 94 is required. In the study mentioned above, there was a dropout rate of about 10%–15%, and a similar rate could be assumed for the present study. However, in order to account for potential attrition, it is prudent to anticipate a higher dropout rate. Accordingly, additional subjects are included for randomisation, resulting in 114 subjects (57 per group) in this study, based on an anticipated dropout rate of up to 20%.
Recruitment
Participants will be recruited using a convenience sampling method. For this study, recruits are primarily recruited from universities, but individuals can apply themselves. The following two main mechanisms will be used to identify and recruit potential subjects: (1) local advertising: posters and fly sheet will be placed on campus; (2) social media promotion: some seed students will post a recruitment message in their WeChat Moments, and those who wish to participate in the study will fill out a screening questionnaire and provide their contact information by clicking a link. The institutional review board will first approve all ads. All individuals who express interest after seeing an advertisement will be screened for eligibility. Eligible participants will be enrolled in the order in which they respond to the recruitment materials until the target sample size of 114 is reached. This process aims to minimise selection bias by systematically enrolling participants on a first-come first-served basis. We recognise that practical sampling limits the representativeness of the study sample. To minimise selection bias, we will aim for a study sample that is representative of the university population in terms of sex, age and other key demographics. We will monitor the characteristics of enrolled participants and adjust recruitment strategies as needed to obtain a sample that closely matches university parameters.
Interventions
Development of the protocol
A goal achievement theory-based PA promotion programme is developed in this study. The aims of the 4- month blended face-to-face and web-based intervention are to support emerging adults to make healthy lifestyle changes (ie, PA level and self-efficacy) and to manage their body composition (ie, skeletal muscle mass, body fat mass, BMI, body fat percentage and waist-to-hip ratio) to reduce their risk of further cardiovascular events, in line with secondary prevention recommendations.31 The study established preliminarily intervention plans according to six relevant clinical guidelines32–37 and two expert consensus.38 39 According to the requirements of this study, a research protocol was formulated and the first draft of the study was reviewed and revised.
Health administrators and emerging adults are included in King’s interpersonal system. Between them exists the nursing process of action, reaction, interaction and transaction. According to this theory, individuals (and groups) achieve their growth and development goals, when they engage in meaningful and gratifying experiences.40 Interaction is a prerequisite for goal setting. The GAT-pap will be administered through interaction and exchange. In this phase, administrators and participants assess the obstacles and issues that may prevent emerging adults from joining the programme. On the basis of the assessments, mutual goals are established, methods for achieving those goals are discussed and a consensus is reached. Once both parties agree on management goals, contracts will be signed between educators and participants to demonstrate their commitment. Figure 2 illustrates the relationship between the concepts in this study.
Figure 2. Flow diagram of goal achievement theory-based diet and exercise intervention.
Treatment group
A researcher (TX) will contact the participants in treatment group within 2 days to record their height, weight and body composition. He will explain their current body composition following the Inbody 720 Results Interpretation Guide. WeChat groups will be created, and articles pertaining to PA will be shared once per week on Monday, while 3 min videos on health education will be shared once per week on Wednesday. Technologies used to deliver the GAT-pap include: (1) Short Message Service (SMS) text (batch messaging); (2) WeChat (eg, Official Accounts, group chats) and (3) monthly face-to-face interviews (behaviour change promotion and risk factor management), all will be provided from the start of recruitment throughout the 3 month intervention period. Participants will be encouraged to log their exercise daily in the group chat. The researchers will create individual training plans for them and assess whether they are meeting their goals and what goals they should be working towards. In addition, three 15 min online courses on various topics will be offered in the first month. The online course schedule is shown in table 1.
Table 1Online course schedules based on King’s three departments
Course topics | Course content* | King’s conceptual system | ||
Personal system | Interpersonal system | Social system | ||
Understanding the benefits of physical activity |
| √ | ||
Building social support for physical activity |
| √ | ||
Creating an active campus environment |
| √ |
*Each lesson can be delivered through a combination of multimedia resources, including videos, interactive quizzes and discussion forums. Additionally, additional resources and references will be provided for further exploration of the topics covered in each lesson.
Text messages will be sent in Chinese or English, depending on participant’s preference. General text messages will be sent once or twice a week with exercise instruction, and a personalised text message will be sent to remind the dates of the next body composition test. Finally, any reports or inquiries from participants received through any of the above channels will be processed. The first author (TX) will seek advice from the team members on answers when necessary.
After each body composition test, with the consent of the participants, a table of changes in body composition over the past month will be compiled in an anonymous form and shared on the WeChat group to allow the participants to understand the changes in themselves and others in the group and to improve their self-perception and motivation for PA.
Control group
Participants in the control group will receive general lifestyle advice via SMS once or twice a week. They will not receive health education videos, group chats, face-to-face meetings, exercise plans or online classes as part of the intervention. Researchers do not provide individual exercise plans, goals or feedback. All reports or inquiries from participants in the control group will be dealt with by responding to general health information and advice. Researchers will not consult other experts or provide individual responses.
Measures
Survey instrument
The questionnaires consist of items on demographic characteristics of the participants, a PA questionnaire, a self-efficacy questionnaire, a goal achievement questionnaire and a motivation level questionnaire.
Participants’ demographic characteristics
Self-reported data will be collected on demographic information: gender (male vs female), age, ethnicity (Han vs minorities), school year (freshman, sophomore, junior, senior, etc.), location (urban vs rural), household income and parental education level.
Outcomes
The main result of interest is body composition (including: body weight (kg), skeletal muscle mass (kg), body fat mass (kg), BMI (kg/m2), body fat percentage (%) and waist-to-hip ratio). Participants will be assessed using a body composition analyzer (Inbody 720). After randomisation, all participants will be surveyed every month for 3 months. During which, they will receive a PA questionnaire, a self-efficacy questionnaire and a goal achievement questionnaire. Follow-up data collection with the Inbody 720 and questionnaires will occur 4 months after the randomisation date.
Primary outcome
Body composition
Bioelectrical impedance analysis with an InBody 720 device will be used to measure the following body composition variables: body weight (kg), skeletal muscle mass (kg), body fat mass (kg); BMI (kg/m2), body fat percentage (%) and waist-to-hip ratio. It is considered statistically reliable and valid for measuring both total and segmental body composition of individuals.41 In accordance with the procedure guiderlines of the InBody device, participants are instructed not to exercise, consume alcohol or excessive caffeine at least 24 hours before the test and not to eat or drink for 4 hours prior to the test, but drink water up to 45 min prior to the test. Meanwhile, participants will be asked to urinate, change into loose-fitting, metal-free athletic attire and remove any jewellery before the test. Height is measured using an electronic scale. Before touching the electrodes, participants will clean their hands and feet with an antibacterial wipe. Standing in an upright position, the participant’s two feet touch the centre of the electrode back and forth, with two thumbs and fingers fully touching the hand electrodes, and two arms are stretched out with no contact to the trunk. This position is maintained throughout the test.
Other outcomes
Physical activity level
The International Physical Activity Questionnaire-Short (IPAQ-S), which has seven items, was translated into Chinese by Macfarlane.42 Patients will recall the frequency and duration of PA and sedentary time within 1 week. Individual physical activity levels are categorized into 3 groups: Vigorous physical activity (all types of high-intensity PA ≥3 days with a total weekly physical activity level ≥1500 MET-min/w or all three types of PA ≥7 days with a total weekly physical activity level ≥3000 MET-min/w, moderate physical activity (all types of high-intensity PA ≥ 20 min/d with a total ≥3 days per week or all types of moderate-intensity PA ≥ 30 min/d with a total ≥5 days per week) and light physical activity (reporting no activity or reporting an activity that does not meet the above criteria). The test–retest reliability of the scale ranged from 0.66 to 0.88.
Self-efficacy
Self-efficacy in exercise refers to a person’s confidence in their capacity to exercise and be physically active.43 Self-efficacy for exercise is essential because it can predict exercise behaviour and PA levels.44 According to research, individuals with greater exercise self-efficacy are more likely to initiate and maintain an exercise programme.45 Those with limited exercise self-efficacy are less likely to initiate or continue an exercise regimen. In PA promotion research, exercise self-efficacy is a crucial psychological construct to examine.
To measure exercise self-efficacy, the shortened physical activity self-efficacy scale (PASEESC) in simplified Chinese will be used.43 The 8-item scale is rated on a Likert scale of 1 to 5 (1=disagree a lot, 5=agree a lot). Higher scores indicate that participants perceive higher self-efficacy. In addition, the scale’s validity and reliability in assessing psychological problems in Chinese adolescents have been demonstrated (Cronbach’s alpha=0.87).46
Goal attainment scores
The Goal Attainment Scaling (GAS), developed by Kiresuk,47 is used to assess participants’ progress in achieving their personal goals during an intervention. This method uses a 5-point Likert scoring system with −2 to –1, 0, 1 and 2 as the scoring standards.48 Prior to the intervention survey, participants will be asked to select 3–5 goals from the indicator pool, and each goal is scored at baseline and expected levels. At the end of the intervention, participants will be given a final actual score for the extent to which each goal has been achieved. The difference between the baseline score and the expected score, the difference between the final score and the expected score and the weighting of participants' goals will be entered into the GAS calculation formula and converted into a standard score with 50 as the mean and 10 as the SD.49 If the final score is ≥50, it means that the target is met or exceeded. If the score is <50, the target is lower than expected.50 The GAS score is calculated using the following formula:
where wi is the weight assigned to the ird goal area, xithe attained score for the ird goal area.
Motivation level
Measurement of changes in motivation levels will be applied using the Treatment Self-Regulation Questionnaire (TSRQ) created by Ryan.51 It consists of 15 items and four dimensions: individual autonomous motivation, internal regulation, external regulation and no motivation. Each item is rated on a scale from 1 (not at all true) to 7 (very true). This instrument has been widely used to measure motivation for healthy behaviours in obese adults.52 Leung adapted the scale to assess autonomous and controlled motivation and conducted a pilot test with mildly obese adults in China.53 The results showed good internal consistency (Cronbach’s α=0.79–0.91) and adequate test–retest reliability (r=0.67–0.97).
Randomisation and blinding
Randomisation
The randomisation protocol will be carried out by an assistant who is not involved in eligibility determination, exercise management or outcome assessment. Eligible participants will be block-stratified and randomised by body fat percentage (female: underweight, ≤20%; normal weight, 21%–32%; overweight, 33%–38%; obesity, ≥39%; male: underweight, ≤7%; normal weight, 8%–19%; overweight, 20%–24%; obesity, ≥25%) in a 1:1 ratio.54 Following informed consent, participants will be assigned to either the control group (CG) or treatment group (TG) 1 week prior to the start of the study using a blocked randomisation algorithm with a block size of four. Randomised sequence numbers will be generated using R software V.4.2.2 RM packages (Lucent Technologies, Murray Hill, NJ, USA).
Blinding
The electronic questionnaires will be designed so that participants in both the intervention and control groups see an identical homepage and registration process. They will not be informed about group assignment at registration.
In the randomised grouping process, the distribution details will be placed in opaque, sealed and numbered envelopes. Researchers are unaware of the block sizes.
Participants in the control group will receive general health information texts unrelated PA. The content will appear similar to the intervention group, but will not contain specific behaviour change guidance.
The face-to-face interviews will be conducted by research staff who are blinded to the group assignment. Data analysts will be blinded to the group assignment until the statistical analyses are completed. Participants, outcome evaluators at the 4 month follow-up and study statisticians will be blinded to the assignment of the intervention.
Data collection and management
Participants, who can be accessed and consent to be contacted with WeChat (https://www.wechat.com), will be identified as study subjects by a member of the research team by searching the registration list and electronic databases of participants.
Participants will be given a choice of how they would like to receive information about their appointment, such as diet and exercise education, planning and follow-up, by phone or WeChat. Study participants will receive an information sheet explaining the purpose of the study. Participants will be informed that they may refuse to participate in the study and may withdraw at any time after they decide to enroll. A consent form will be required from all those who agree to participate.
Body composition is measured by two trained researchers using the InBody 720 in the rehabilitation laboratory at baseline (T0), each month during the procedure (T1–T3) and 1 month after the end of the procedure (T4). Other questionnaires will be filled out online (https://www.wjx.cn/) by the participants themselves. The data collection schedule is shown in table 2.
Table 2Time schedule of enrolment, interventions and assessments
Enrolment | Allocation | Baseline | Follow-up | Close-out | |||
Timepoint | T1 | 0 | 0 | T1 (1st month) | T2 (2nd month) | T3 (3rd month) | T4 (4th month) |
Enrolment | |||||||
Eligibility screen | × | ||||||
Informed consent | × | ||||||
Allocation | × | ||||||
Interventions | |||||||
Usual management group | |||||||
Goal-attainment-theory-based self-management group | |||||||
Assessments | |||||||
Self-designed questionnaire (include demographics, age, disease history) | × | ||||||
Physical activity | × | × | × | × | × | ||
Body height | × | ||||||
Body composition | × | × | × | × | × | ||
Self-efficacy | × | × | × | × | × | ||
Score of the Goal Attainment Scaling | × | × | × | × | × | ||
Score of the Treatment Self-Regulation Questionnaire | × | × | × | × | × |
A data manager maintains study-related data. The data manager will check for inconsistencies between the data for statistical analysis and the original data and corrections will be made if inconsistent. All forms pertaining to the study’s data will be stored in a secure container. The availability of research data will be restricted. Only members of the research team will have access to the study-specific research folder. A password system will be used to control access, with passwords being periodically altered.
Statistical methods
Confounders
Confounding relationships of intervention–mediator and intervention–outcome were not hypothesised, due to the random assignment of subject groups. A directed acyclic graph (DAG) was created in order to discover potential confounding variables that may affect the relationship between the mediator and outcome variables of interest before any intervention55 (see online supplemental file 2). This was revised based on relevant scholarly sources and feedback from peers.56–58 According to our DAG, it was determined that adjustment for several pretreatment confounders was necessary. These confounders include age, sex, self-efficacy, education level, family income, health knowledge and parents’ level of education.
Statistical analysis
For statistical analysis, SPSS V.26.0 will be used. All statistical tests will be two-tailed, and a p≤0.05 will be considered statistically significant. The descriptive data will be presented as mean±SD for continuous variables (such as height, weight, skeletal muscle and health scores), as well as number and percentage for categorical variables, including sex, dietary preferences, etc. Independent t-tests or Mann-Whitney U tests (depending on the normality of data distribution) will be used to compare changes in continuous variables (eg, body composition, PA and self-efficacy) from baseline to follow-up between the intervention and control groups. χ2 tests will be used to compare changes in categorical variables (eg, diet preferences) between groups. Analysis of covariance will be conducted to compare follow-up outcomes between groups, adjusting for baseline values as covariates. Multiple linear regression will be performed to identify predictors of changes in outcomes within the intervention group.
Missing data
The preliminary analysis of all outcomes will include all randomised participants. To treat missing values, this study will estimate the missing values using the multiple estimation method with full conditional specification regression.59
Ethical considerations
Participants will be motivated by the novel management strategy that may help the emerging adults with physical inactivity. Participants will not be exposed to any potentially harmful procedures or therapies. No additional risks are to be expected compared with standard health management. Participants will only be asked to complete additional questionnaires at baseline, 1, 2, 3, and 4 months. The online questionnaire can be completed conveniently at home in order to minimise the additional burden for the participants.
All participants identified for this study will sign an informed consent form on receipt of appropriate information. The Medical Ethics Committee of the correspongding author’s affiliated institution has reviewed and approved this protocol. The informed consent forms (online supplemental file 3) adhere to scientific standards and compliance with relevance research and subject regulations (ratification date: 14 November 2022, 2022059). The ethical review committee also reviewed other related documents, including site-specific consent forms, participant training and recruitment materials. This committee will also assess any subsequent revisions that may be made to these documents. Documentation of ethical protocols and scientific practices can be accessed at https://osf.io/4huz9/.
Harms
Any unintended negative health outcome for a research participant is considered an adverse event, regardless of what causes it. After subjects have given informed consent and joined the study, data on adverse events will be collected. An adverse event is determined to be unrelated to the health intervention if it occurs after the subject signs the informed consent form (enrolment) but before the subject has started the research intervention. Adverse occurrences after enrolment will be carefully documented. Serious adverse events (SAEs) will be reported to the Ethics Committee of Hangzhou Normal University if they meet the criteria established at enrolment. For the purposes of this study, an SAE is defined as any medical complication that is either life-threatening (ie, presents an imminent risk of death), causes severe or permanent disability or poses a significant risk, as determined by the Data Safety Monitoring Board. After a subject withdraws from the study, SAEs that occur will not be disclosed unless the investigator has reason to suspect that they are caused by the experimental methods.
Patient and public involvement
Patients or public were not involved in the design or conduct of the study.
Discussion
Physical inactivity is currently one of the major health problems worldwide, and sedentary behaviour is associated with an increased risk of obesity and a contribution to the development of cardiovascular diseases.60 To aid weight reduction in emerging adults, it is advised that general suggestions be followed regarding a balanced diet and physical exercise. However, lifestyle therapies, such as calorie-restricted diets in general and low-fat or low-carbohydrate diets with or without increased PA, are often associated with poor adherence and high drop-out and relapse rates in young people. In this research, a web-based and face-to-face blended intervention is used to provide emerging adults with additional social and peer support, which improves participants’ adherence to the intervention.
There are several salient features of this current study. First, this study applies the King’s goal attainment theory to the promotion of PA in emerging adults, focusing on the mutual influence between health managers and clients through the establishment of specific relationships in a perceptive, interactive and communicative manner, requiring participants and researchers to participate in the promotion activities and interacting together, changing the traditional intervention model and encouraging both parties to set goals mutually and interact harmoniously to achieve their goals. Second, it confirms that perceived interpersonal support is better at predicting positive health outcomes.61 Closed peer support groups used in the PA intervention will provide study participants with informative and emotional social support. In addition, fewer exclusion criteria makes it easier to increase the number of participants and extend the scope of the study. Finally, before the randomisation procedure begins, the methodology will be explained in detail thereby mitigating the data-based prejudice.
There are also some limitations that need to be addressed. First, while some measures were taken to ensure blinded test results, this study was somewhat limited in terms of blinding due to the nature of the intervention. In addition, the difficulty of recruiting men for the study is well documented.62 However, body composition tests are usually available for a fee but are offered free during the trial period, so we predict that the free body composition test should be of interest to men. Besides, participants who do not wish to meet for offline follow-up will be asked to complete the assessment over the phone (although unfortunately, this will introduce bias as there is no blind approach in this case). Finally, a potential limitation is that the study sample may not be fully representative of the large scale population.
We thank the librarian, Jian Zu, for the purchase of books related to this study, and the library archivist, Lifang He, for her help in literature searches related to the theory of this study.
Ethics statements
Patient consent for publication
Consent obtained directly from patient(s).
Contributors TX and YT identified the research question and designed the study protocol. RC contributed to the development and design of the intervention content. XC and CL contributed to the study design and manuscript writing. GS provided critical feedback on the study design and manuscript writing. All authors read and approved the final manuscript.
Funding This work was supported by the Construction Project of Geriatric Nursing Discipline (ZX13013001002). This funding source played no role in the study's design and will play no role in its implementation, analysis, data interpretation or decision to present results.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
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Abstract
Introduction
A dramatic decline in physical activity may occur in emerging adulthood because of a major transition over the course of a life. The potential for implementing structured behaviour modification strategies to enhance risk-reducing clinical outcomes is widely recognised. The active participation of clients in the discussion and care process is crucial for optimising intervention outcomes and enhancing individuals’ motivation to adopt and maintain healthy behaviours. This study therefore aims to evaluate the effectiveness of a physical activity promotion programme based on the goal attainment theory in relation to emerging adults’ body composition, using a face-to-face and e-health blended interventions.
Methods and analysis
A two-arm, double-blind, randomised, controlled study will be conducted in 114 university students aged 18–25 years with physical inactivity. The intervention assignment will be blind to study participants, outcome assessors and study statisticians. A goal achievement theory-based physical activity promotion programme is developed in this study, which is a 16-week, face-to-face and e-health-blended physical activity promotion intervention. After informed consent, participants will be randomly assigned to either a control group or a treatment group before the start of the study. The primary outcome is body composition (ie, skeletal muscle mass, body fat mass, body mass index and body fat percentage). Other outcomes include physical activity level, goal attainment scale scores, exercise self-efficacy and motivation level, which will be assessed during the intervention (every 4 weeks) and at the 1 month follow-up. Continuous variables have means and SD, while categorical variables have frequencies and percentages. Independent-samples t-tests will be used to compare continuous variable changes. χ2 tests will be used to compare categorical variable changes. Based on the baseline scores, analysis of covariance will compare the follow-up results.
Ethics and dissemination
This study was approved by the Ethics Committee of Hangzhou Normal University (ratification date: 14 November 2022, 2022059). The results of the study will be submitted for publication and dissemination in a peer-reviewed journal.
Trial registration number
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