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NCT05697679 | Active, not recruiting | Body Composition


Effects of Physical Activity Promotion Intervention Programs in Emerging Adulthood
Sponsor:

X u tao

Information provided by (Responsible Party):

X u tao

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.

Condition or disease

Body Composition

Health Behavior

Intervention/treatment

Treatment group

Control group

Phase

Not Applicable

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, 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.}}

Study Type : Interventional
Estimated Enrollment : 86 participants
Masking : Double
Masking Description : 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.
Primary Purpose : Other
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
Actual Study Start Date : June 28, 2023
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : November 30, 2023
Arm Intervention/treatment

Experimental: Usual management group

The intervention group is intervened with the TG

Behavioral: Treatment group

Active Comparator: Goal-attainment-theory-based self-management group

The group is intervened with the CG

Behavioral: Control group

Ages Eligible for Study: 18 Years to 25 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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.

Effects of Physical Activity Promotion Intervention Programs in Emerging Adulthood

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Effects of Physical Activity Promotion Intervention Programs in Emerging Adulthood

How to Participate

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Locations


Not yet recruiting

China, Zhejiang

Hangzhou Normal University

Hangzhou, Zhejiang, China, 311121

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