Effects of Physical Activiy Promotion Intervention Programs in Emerging Adulthood

Health Behavior Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05697679
• Other study ID #: 2022059
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2023
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The aim of this study is to investigate the impact of physiological indicators and health behaviours by conducting an exerciset programme and intensive therapy.

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, 16-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 16 weeks of all of the participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: November 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Composition
• Health Behavior

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
China	Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Xu Tao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before and 16 weeks after the intervention
Secondary	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.	Before and 16 weeks after the intervention
Secondary	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 a 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	Before and 16 weeks after the intervention
Secondary	Goal Attainment scores	The Goal Attainment Scaling (GAS), developed by Kiresuk, 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, -1, 0, 1 and 2 as the scoring standards	Before and 16 weeks after the intervention
Secondary	Motivation level	Measurement of changes in motivation levels will be applied using the Treatment Self-Regulation Questionnaire (TSRQ) created by Ryan	Before and 16 weeks after the intervention