Effects of Eating-Exercise Intervention Programs in Emerging Adulthood

Sponsor
Xu Tao (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05697679
Collaborator
(none)
86
1
2
10.1
8.6

Study Details

Study Description

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, eating habits, eating attitudes and health behaviours by conducting an exercise and diet programme and intensive therapy.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Releasing Weight-1
  • Behavioral: Releasing Weight-2
N/A

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. This is followed by a detailed 16-week intervention program consisting of jogging and High-intensity Interval Training. The training program is structured in three cycles, with an incremental pattern: both frequency and duration of the sessions are increased. Each session is composed of a warm-up, a high-intensity interval exercise, and a cool down. Weekly information reminders are provided through Wechat and the exercise plan is timely adjusted according to personal conditions. Participants are asked to record their daily diet, and their diet is assessed weekly and given professional advice.

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), the Short-form Eating Behavior Scale (SEBS).

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 Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (Participant, Outcomes Assessor)
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 Eating-Exercise Intervention Based on King's Goal Attainment Theory in Emerging Adulthood: A Randomized Controlled Trial
Anticipated Study Start Date :
Feb 28, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Usual management group

The intervention group is intervened with the RELE-W-1 plan

Behavioral: Releasing Weight-1
Perception: Data such as diet and exercise are evaluated at baseline to make participants feel the current problem. After communication, personalized plans are made and implemented together. After grouping, the training of diet and exercise related knowledge is carried out for one week, and the activation training of physical movement ability is carried out in the second week. This is followed by a detailed 16-week intervention program consisting of jogging and High-intensity Interval Training. The training program is structured in three cycles, with an incremental pattern: both frequency and duration of the sessions are increased. Each session is composed of a warm-up, a high-intensity interval exercise, and a cool down. Weekly information reminders are provided through Wechat and the exercise plan is timely adjusted according to personal conditions. Participants are asked to record their daily diet, and their diet is assessed weekly and given professional advice.
Other Names:
  • RELE-W-1
  • Active Comparator: Goal-attainment-theory-based self-management group

    The group is intervened with the RELE-W-2 plan

    Behavioral: Releasing Weight-2
    Health education is carried out by distributing diet and exercise related knowledge manuals and videos, and health plans are made. The exercise is evaluated once a month and the diet is evaluated once a week.
    Other Names:
  • RELE-W-2
  • Outcome Measures

    Primary Outcome Measures

    1. Assessment of changes in body composition [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.

    Secondary Outcome Measures

    1. Changes in eating behavior [Before and 16 weeks after the intervention]

      The Short-form Eating Behavior Scale (EBS-SF), is a reliable and valid measure as an indicator of obesity in both clinical and research settings. The EBS-SF was scored on a 4-point Likert scale indicating the residents' degree of agreement (1 = strongly disagree, 2 = somewhat disagree, 3 = somewhat agree, and 4 = strongly agree), and seven items were summed to obtain scores between 7 and 28, with higher scores indicating worse eating behavior. The Cronbach's α of the EBS-SF was 0.871, showing that it had good internal consistency.

    2. Changes in amount of physical activety [Before and 16 weeks after the intervention]

      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.

    3. Changes in self-efficacy [Before and 16 weeks after the intervention]

      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

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hangzhou Normal University Hangzhou Zhejiang China 311121

    Sponsors and Collaborators

    • Xu Tao

    Investigators

    • Principal Investigator: Tao Xu, Hangzhou normal univesity

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xu Tao, Principal Investigator, Hangzhou Normal University
    ClinicalTrials.gov Identifier:
    NCT05697679
    Other Study ID Numbers:
    • 2022059
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xu Tao, Principal Investigator, Hangzhou Normal University

    Study Results

    No Results Posted as of Jan 26, 2023