Body CompositionNCT05697679
Effects of Physical Activiy Promotion Intervention Programs in Emerging Adulthood
A study testing Treatment group and Contral group in people with Body Composition and Health Behavior, run by Xu Tao at 1 site in China.
Trial summary
This is a prospective, double-blinded, 16-week, randomized controlled trial (RCT). Young adults aged 18-25 years are recruited in this study. Based on King's (1981) goal attainment theory, a diet-exercise program is created. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Health Behavior
- What is being tested?
- Treatment group and Contral group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a sedentary lifestyle. ( Sedentary behavior is defined as any waking behavior characterized by an energy expenditure ≤ 1.5 metabolic equivalents, such as sitting, reclining or lying down. )
Who cannot join
- Diabetes
- Cardiovascular disease risk
- Upper respiratory infection
- Smoking
- Injury or disease that limited exercise ability
- Using of any medication within the last 3 months
Show all 11Show fewer
- Lactose intolerance
- Celiac diseas
- Food allergies
- Specific dietary regiments (e.g., vegetarian diet, intermittent fasting or less common diets)
- Pregnancy or planning pregnancy during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Physical Activity Promotion Program on Body Composition in Emerging Adults With Physical Inactivity: A Study Protocol of a Randomized Controlled Trial
This is a prospective, double-blinded, 16-week, randomized controlled trial (RCT). Young adults aged 18-25 years are recruited in this study. Based on King's (1981) goal attainment theory, a diet-exercise program is created. The aim of this study is to investigate the impact of physiological indicators and health behaviours by conducting an exerciset programme and intensive therapy.
Read the detailed description
Background:
Emerging adulthood (18-25 years), has been linked to increased probability of unhealthy and risky lifestyle behaviours, such as alcohol, tobacco and other drug use, dangerous driving, unprotected sex, and unhealthy dietary choices. These lifestyle behaviours are associated with some of the key leading causes of premature death and disease burden in this age group. Thus, reducing the prevalence of risky and unhealthy lifestyle behaviours among emerging adults is a priority for health promoters and governments.
Aim:
The researchers hypothesize that a health program based on King's goal achievement theory have a significant effect on body composition among college students. Therefore, in this study, researchers will explore the impact of a health program based on King's goal achievement theory on the body composition of college students.
Methods:
This is a prospective, double-blinded, 12-week, randomized controlled trial in Hangzhou. Participants are randomly allocated in a 1:1 ratio to two groups using blocked randomization. WeChat groups will be set up, and once a week on Monday, articles on physical exercise and once a week on Wednesday, 3-minute films about health education will be shared. For the duration of the 3-month intervention period, the following technologies will be used to deliver the GAT-pap: (1) Short Messaging Service (SMS) text (batch messaging); (2) WeChat (e.g., physical activity guidelines, group chats); and (3) monthly face-to-face interviews (behaviour change promotion, risk factor management). Although not essential, participants will be urged to register their daily exercise in the group chat. In order to determine if they are accomplishing their goals and what objectives they should be pursuing, the researchers will develop customised training regimens for each participant.
Participants and demographic data:
Healthy individuals with a sedentary lifestyle will be recruited to participate in the study through online and print advertisements posted at Hangzhou Normal University (Hangzhou, China) and surrounding communities. Sedentary behavior is defined as any waking behavior characterized by an energy expenditure ≤ 1.5 metabolic equivalents, such as sitting, reclining or lying down. The participants are able to express themselves and to individually complete the International Physical Activity Questionnaire (IPAQ)
Procedure and Data collection:
This is a prospective, double-blinded, 16-week, randomized controlled trial (RCT) complied with the ethical principles of the Helsinki Declaration and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. It was approved by the Medical Ethical Committee of the Hangzhou Normal University (Ratification date is November 14, 2022, 2022059)
Statistical analysis:
This study will employ Predictive Analytics Suite Workstation (IBM SPSS 28.0) to analyze the collected data. The data analyses will include demographic variables and the scores of IPAQ, SBES at the interval of 12 weeks of all of the participants.
- Conditions
- Body Composition, Health Behavior
- Being tested
- Treatment group, Contral group
- Keywords
- Body composition, Theory of goal attainment, Eating behavior, Health behavior
- Medical subject headings
- Health Behavior, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment groupBehavioural
Also called TG
WeChat groups will be set up, and once a week on Monday, articles on physical exercise and once a week on Wednesday, 3-minute films about health education will be shared. For the duration of the 3-month intervention period, the following technologies will be used to deliver the GAT-pap: (1) Short Messaging Service (SMS) text (batch messaging); (2) WeChat (e.g., physical activity guidelines, group chats); and (3) monthly face-to-face interviews (behaviour change promotion, risk factor management). Although not essential, participants will be urged to register their daily exercise in the group chat. In order to determine if they are accomplishing their goals and what objectives they should be pursuing, the researchers will develop customised training regimens for each participant.
Contral groupBehavioural
Also called CG
One or two times each week, participants in the control group will get general lifestyle advice through SMS. They will not participate in the intervention's fitness routines, online classes, group chats, or films with health educators. Individual workout regimens, goals, or comments are not given by researchers. Participants in the control group's complaints or questions will always be answered with basic health information and suggestions. Researchers won't ask for individual advice or comments from other professionals.
| Study group | Role | What they receive |
|---|---|---|
| Usual management group | Experimental | The intervention group is intervened with the TG Receives: Behavioral: Treatment group |
| Goal-attainment-theory-based self-management group | Active comparator | The group is intervened with the CG Receives: Behavioral: Contral group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in body composition
Participants will have body composition measured by using bioelectrical impedance analysis (BIA) with InBody 720 device. According to the InBody device manufacturer's testing procedures, participants will be told not to exercise for at least 24 hours before the test, not to consume alcohol or excessive amounts of caffeine, and not to eat and drink for four hours before the test, but water can be consumed up to 45 minutes before the test.
Measured: Before and 16 weeks after the intervention
Secondary outcomes (3)
Changes in amount of physical activety
The International Physical Activity Questionnaire-Short Form (IPAQ-SF) prepared by the International Working Group on Physical Activity Measurement, was selected to investigate the physical activity levels. The IPAQ has been translated into Chinese with a good reliability and validity. There are 7 items in the questionnaire. Three intensities of physical activities during the last seven days were collected, including (1) vigorous-intensity activities such as speed swimming or playing basketball, (2) moderate-intensity activities such as slow dancing or strenuous household chores, and (3) low-intensity activities such as walking. Each activity had its own metabolic equivalent (MET) energy expenditure, and the vigorous-, moderate-, and low-intensity activities equaled 8.0, 4.0, and 3.3 METs. The amount of physical activity was estimated by weighting the intensity and time spent performing each activity with its MET.
Measured: Before and 16 weeks after the intervention
Changes in self-efficacy
The Simplified Chinese version of the Health-Related Diet and Exercise Self-Efficacy Scale (HRDESES) included 8 items under 2 dimensions: diet subscale and exercise subscale. Response options are rated on a 5-point scale: 0 (I'm not sure), 1 (mostly I cannot), 2 (don't know), 3 (mostly I can), or 4 (I'm sure I can). The total score ranges from 0 to 32, with a higher score indicating higher levels of health-related diet and exercise self-efficacy. The Cronbach's α of the HRDESES was 0.87 for the total scale, 0.86 for the diet The simplified Chinese version of the health-related diet and exercise self-efficacy scale subscale and 0.91 for the exercise subscale
Measured: Before and 16 weeks after the intervention
Motivation level
Measurement of changes in motivation levels will be applied using the Treatment Self-Regulation Questionnaire (TSRQ) created by Ryan
Measured: Before and 16 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start28 Jun 2023
- Primary completion30 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is based on a stratified randomized controlled design with two groups. The stratification is done with four groups based on the BMI (underweight, ≤18.5; normal weight, 18.5-24.0; overweight, 24.0-28.0; obesity, BMI of 28 or greater) indicated at registration. Each participant is randomly assigned to either the different group 1 week before the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xu Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu Tao, Hangzhou Normal University
- Investigators
- Tao Xu, Principal investigator, Hangzhou normal univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697679
- Sponsor's protocol ID
- 2022059
- Status last verified
- Aug 2024
- First submitted
- 29 Dec 2022
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu T, Liu CY, Tao YX, Cai XT, Wu YY, Chen R, Xiao T, Liu MY. Effects of a goal attainment theory-based intervention on physical activity, body composition, and motivation in emerging adults with physical inactivity: A randomized controlled trial. Public Health. 2025 Jan;238:280-288. doi: 10.1016/j.puhe.2024.12.007. Epub 2024 Dec 19.
PubMed 39706105Xu T, Tao Y, Chen R, Strachan G, Cai X, Liu C. Effects of a physical activity promotion programme on body composition in emerging adults with physical inactivity: a study protocol of a randomised controlled trial. BMJ Open. 2023 Oct 5;13(10):e076123. doi: 10.1136/bmjopen-2023-076123.
PubMed 37798029
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physical Activity Promotion Program on Body Composition in Emerging Adults With Physical Inactivity: A Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05697679
- Acronym / sponsor ID
- 2022059
- Conditions
- Body Composition, Health Behavior
- Keywords
- Body composition, Theory of goal attainment, Eating behavior, Health behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Xu TaoUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, double-blinded, 16-week, randomized controlled trial (RCT). Young adults aged 18-25 years are recruited in this study. Based on King's (1981) goal attainment theory, a diet-exercise program is created. The aim of this study is to investigate the impact of physiological indicators and health behaviours by conducting an exerciset programme and intensive therapy.
Detailed description
Background:
Emerging adulthood (18-25 years), has been linked to increased probability of unhealthy and risky lifestyle behaviours, such as alcohol, tobacco and other drug use, dangerous driving, unprotected sex, and unhealthy dietary choices. These lifestyle behaviours are associated with some of the key leading causes of premature death and disease burden in this age group. Thus, reducing the prevalence of risky and unhealthy lifestyle behaviours among emerging adults is a priority for health promoters and governments.
Aim:
The researchers hypothesize that a health program based on King's goal achievement theory have a significant effect on body composition among college students. Therefore, in this study, researchers will explore the impact of a health program based on King's goal achievement theory on the body composition of college students.
Methods:
This is a prospective, double-blinded, 12-week, randomized controlled trial in Hangzhou. Participants are randomly allocated in a 1:1 ratio to two groups using blocked randomization. WeChat groups will be set up, and once a week on Monday, articles on physical exercise and once a week on Wednesday, 3-minute films about health education will be shared. For the duration of the 3-month intervention period, the following technologies will be used to deliver the GAT-pap: (1) Short Messaging Service (SMS) text (batch messaging); (2) WeChat (e.g., physical activity guidelines, group chats); and (3) monthly face-to-face interviews (behaviour change promotion, risk factor management). Although not essential, participants will be urged to register their daily exercise in the group chat. In order to determine if they are accomplishing their goals and what objectives they should be pursuing, the researchers will develop customised training regimens for each participant.
Participants and demographic data:
Healthy individuals with a sedentary lifestyle will be recruited to participate in the study through online and print advertisements posted at Hangzhou Normal University (Hangzhou, China) and surrounding communities. Sedentary behavior is defined as any waking behavior characterized by an energy expenditure ≤ 1.5 metabolic equivalents, such as sitting, reclining or lying down. The participants are able to express themselves and to individually complete the International Physical Activity Questionnaire (IPAQ)
Procedure and Data collection:
This is a prospective, double-blinded, 16-week, randomized controlled trial (RCT) complied with the ethical principles of the Helsinki Declaration and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. It was approved by the Medical Ethical Committee of the Hangzhou Normal University (Ratification date is November 14, 2022, 2022059)
Statistical analysis:
This study will employ Predictive Analytics Suite Workstation (IBM SPSS 28.0) to analyze the collected data. The data analyses will include demographic variables and the scores of IPAQ, SBES at the interval of 12 weeks of all of the participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study is based on a stratified randomized controlled design with two groups. The stratification is done with four groups based on the BMI (underweight, ≤18.5; normal weight, 18.5-24.0; overweight, 24.0-28.0; obesity, BMI of 28 or greater) indicated at registration. Each participant is randomly assigned to either the different group 1 week before the study.
| Arm | Type | Receives |
|---|---|---|
| Usual management group | Experimental | Behavioral: Treatment groupThe intervention group is intervened with the TG |
| Goal-attainment-theory-based self-management group | Active comparator | Behavioral: Contral groupThe group is intervened with the CG |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Having a sedentary lifestyle. ( Sedentary behavior is defined as any waking behavior characterized by an energy expenditure ≤ 1.5 metabolic equivalents, such as sitting, reclining or lying down. )
Key exclusion criteria (11 listed)
- Diabetes
- Cardiovascular disease risk
- Upper respiratory infection
- Smoking
- Injury or disease that limited exercise ability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment groupAlso: TGWeChat groups will be set up, and once a week on Monday, articles on physical exercise and once a week on Wednesday, 3-minute films about health education will be shared. For the duration of the 3-month intervention period, the following technologies will be used to deliver the GAT-pap: (1) Short Messaging Service (SMS) text (batch messaging); (2) WeChat (e.g., physical activity guidelines, group chats); and (3) monthly face-to-face interviews (behaviour change promotion, risk factor management). Although not essential, participants will be urged to register their daily exercise in the group chat. In order to determine if they are accomplishing their goals and what objectives they should be pursuing, the researchers will develop customised training regimens for each participant. | Behavioural | Usual management group |
| Contral groupAlso: CGOne or two times each week, participants in the control group will get general lifestyle advice through SMS. They will not participate in the intervention's fitness routines, online classes, group chats, or films with health educators. Individual workout regimens, goals, or comments are not given by researchers. Participants in the control group's complaints or questions will always be answered with basic health information and suggestions. Researchers won't ask for individual advice or comments from other professionals. | Behavioural | Goal-attainment-theory-based self-management group |
Primary outcome
Assessment of changes in body composition
Time frame: Before and 16 weeks after the intervention
Participants will have body composition measured by using bioelectrical impedance analysis (BIA) with InBody 720 device. According to the InBody device manufacturer's testing procedures, participants will be told not to exercise for at least 24 hours before the test, not to consume alcohol or excessive amounts of caffeine, and not to eat and drink for four hours before the test, but water can be consumed up to 45 minutes before the test.
3 secondary outcomes
Changes in amount of physical activety
Time frame: Before and 16 weeks after the intervention
Changes in self-efficacy
Time frame: Before and 16 weeks after the intervention
Motivation level
Time frame: Before and 16 weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Derived from this study: PubMed 39706105Xu T, Liu CY, Tao YX, Cai XT, Wu YY, Chen R, Xiao T, Liu MY. Effects of a goal attainment theory-based intervention on physical activity, body composition, and motivation in emerging adults with physical inactivity: A randomized controlled trial. Public Health. 2025 Jan;238:280-288. doi: 10.1016/j.puhe.2024.12.007. Epub 2024 Dec 19.
- Derived from this study: PubMed 37798029Xu T, Tao Y, Chen R, Strachan G, Cai X, Liu C. Effects of a physical activity promotion programme on body composition in emerging adults with physical inactivity: a study protocol of a randomised controlled trial. BMJ Open. 2023 Oct 5;13(10):e076123. doi: 10.1136/bmjopen-2023-076123.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Xu principal investigator
Hangzhou normal univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment group and Contral group in people with Body Composition and Health Behavior, run by Xu Tao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of changes in body composition (time frame: Before and 16 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697679, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.