Clinical trial NCT05697679: Effects of Physical Activiy Promotion Intervention Programs in Emerging Adulthood
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Composition
Health Behavior
Keywords: Body composition
Theory of goal attainment
Eating behavior
Health behavior
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of changes in body composition
timeFrame: Before and 16 weeks after the intervention
Secondary outcomes:
measure: Changes in amount of physical activety
timeFrame: Before and 16 weeks after the intervention
measure: Changes in self-efficacy
timeFrame: Before and 16 weeks after the intervention
measure: Motivation level
timeFrame: Before and 16 weeks after the intervention
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Normal University
state: Zhejiang
Study officials:
affiliation: Hangzhou normal univesity
name: Tao Xu
role: PRINCIPAL_INVESTIGATOR
References: