Effects of Physical Activiy Promotion Intervention Programs in Emerging Adulthood

NCT ID: NCT05697679

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-28

Study Completion Date

2024-06-30

Brief Summary

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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

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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

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Body Composition Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The first author will use randomizer.org for randomization. Recruitment without informing the subjects of study participation and group allocation to blind the subjects. And the allocation is also concealed for researchers in charge of data collection and processing.

Study Groups

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Usual management group

The intervention group is intervened with the TG

Group Type EXPERIMENTAL

Treatment group

Intervention Type BEHAVIORAL

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.

Goal-attainment-theory-based self-management group

The group is intervened with the CG

Group Type ACTIVE_COMPARATOR

Contral group

Intervention Type BEHAVIORAL

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.

Interventions

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Treatment group

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.

Intervention Type BEHAVIORAL

Contral group

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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TG CG

Eligibility Criteria

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Inclusion Criteria

* 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. )

Exclusion Criteria

* Diabetes
* Cardiovascular disease risk
* Upper respiratory infection
* Smoking
* Injury or disease that limited exercise ability
* Using of any medication within the last 3 months
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xu Tao

OTHER

Sponsor Role lead

Responsible Party

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Xu Tao

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tao Xu

Role: PRINCIPAL_INVESTIGATOR

Hangzhou normal univesity

Locations

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Hangzhou Normal University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 39706105 (View on PubMed)

Xu 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.

Reference Type DERIVED
PMID: 37798029 (View on PubMed)

Other Identifiers

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2022059

Identifier Type: -

Identifier Source: org_study_id

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