NCT05697679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

June 28, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

December 29, 2022

Last Update Submit

August 15, 2024

Conditions

Keywords

Body compositionTheory of goal attainmentEating behaviorHealth behavior

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in amount of physical activety

    Before and 16 weeks after the intervention

  • Changes in self-efficacy

    Before and 16 weeks after the intervention

  • Motivation level

    Before and 16 weeks after the intervention

Study Arms (2)

Usual management group

EXPERIMENTAL

The intervention group is intervened with the TG

Behavioral: Treatment group

Goal-attainment-theory-based self-management group

ACTIVE COMPARATOR

The group is intervened with the CG

Behavioral: Contral group

Interventions

Treatment groupBEHAVIORAL

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.

Also known as: TG
Usual management group
Contral groupBEHAVIORAL

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.

Also known as: CG
Goal-attainment-theory-based self-management group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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. )

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou Normal University

Hangzhou, Zhejiang, 311121, China

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Health BehaviorFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Study Officials

  • Tao Xu

    Hangzhou normal univesity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2022

First Posted

January 26, 2023

Study Start

June 28, 2023

Primary Completion

May 30, 2024

Study Completion

June 30, 2024

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations