Behavior Intervention for Weight Loss for Type 2 Diabetes Mellitus Adults With Obesity Problem (BMI of ≥23kg/m2)

Sponsor
Universiti Teknologi Mara (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05736536
Collaborator
(none)
124
2
2

Study Details

Study Description

Brief Summary

This quasi-experimental study aims to determine the effectiveness of a health intervention (Chance2Act) on behaviour change to act for weight loss among overweight/obese type 2 diabetes adults.

The main question it aims to answer is:
  • Is the new health intervention (Chance2Act) effective in changing overweight/obese type 2 diabetes adults from not being ready to act, to take action to lose weight?
Condition or Disease Intervention/Treatment Phase
  • Behavioral: Chance2Act
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Health Intervention on Behaviour Change to Act for Adults With Type 2 Diabetes Mellitus and Body Mass Index of ≥ 23kg/m2: a Quasi-Experimental Study
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

This group will receive a package of health education modules through Chance2Act website in addition to the existing health education being offered in the health clinic.

Behavioral: Chance2Act
A Health education package that has been developed based on Transtheoretical Model to encourage behaviour change for weight loss among overweight/obese type 2 diabetes adults.

No Intervention: Control Group

This group will receive the existing health education being offered in the health clinic.

Outcome Measures

Primary Outcome Measures

  1. Changes of readiness to change for weight loss (behaviour) [T0 (Week 0), T1 (Week 5), T2 (Week 9)]

    The stage of change for weight loss is based on the S-weight questionnaire (Transtheoretical Model). Data type: Categorical data (either in pre-contemplation, contemplation, preparation, or action stage)

Secondary Outcome Measures

  1. Changes of self-efficacy for weight loss (behaviour) [T0 (Week 0), T1 (Week 5), T2 (Week 9)]

    The changes for self-efficacy to control eating impulses based on Weight Efficacy Lifestyle Questionnaire (Transtheoretical Model). Domains (4 items in each domain) Negative emotions Availability Social Pressure Physical discomfort Positive Activities Data type: Numerical data. A higher score shows better outcomes. Rating of each item: 0 - 9 Lowest score: 0 in each subscale Highest score: 36 in each subscale

  2. Changes of decisional balance for weight loss (behaviour) [T0 (Week 0), T1 (Week 5), T2 (Week 9)]

    The changes for decisional balance to decide on the pros and cons of weight loss based on the Decisional Questionnaire Inventory questionnaire (Transtheoretical Model). Domains (10 items in each domain) Pro scale (Measure the positive effects from weight loss. A higher score shows better outcomes) Con scale (Measure the negative effects from weight loss. A higher score shows worse outcomes) Rating of each item: 1 - 5 Data type: Numerical data. Lowest score: 10 in each subscale Highest score: 50 in each subscale

  3. Changes in family support for healthy diet and physical activity to encourage weight loss (social support) [T0 (Week 0), T1 (Week 5), T2 (Week 9)]

    The changes for social support for weight loss based on the Social Support Scale for Diet and Exercise Domains: Family support for physical activity (12 items) Family encouragement for healthy diet (5 items) Family discouragement for healthy diet (5 items) Rating for each item: 1 - 5 Data type: Numerical data. Total subscale score: Family support for physical activity: 12 - 60: A higher score shows better outcomes. Family encouragement for healthy eating 5 - 25: A higher score shows better outcomes. Family discouragement for healthy eating 5 - 25: A higher score shows worse outcomes

  4. Changes body mass index (anthropometric) [T0 (Week 0), T1 (Week 5), T2 (Week 9)]

    The changes body mass index measurement

  5. Changes waist circumference (anthropometric) [T0 (Week 0), T1 (Week 5), T2 (Week 9)]

    The changes waist circumference measurement

  6. Changes in body fat composition (anthropometric) [T0 (Week 0), T1 (Week 5), T2 (Week 9)]

    The changes in body fat composition (total and visceral fat)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • T2DM patients under follow-up of government health clinics Kuantan, Pahang.

  • Age between 20 - 65 years old.

  • Body Mass Index of more or equal to 23 kg/m2.

  • In the stage of pre-contemplation, contemplation, or preparation stage of change based on the S-weights questionnaire.

  • Able to understand, read and write in the Malay Language.

  • Have access to smartphone devices and internet services.

  • Have immediate family members (adults) who are living in the same household.

Exclusion Criteria:
  • Pregnant patients.

  • Patients' advanced comorbidity that will affect participation in the study protocol (e.g. vision problem, unable to walk or physically unfit to stand up, advanced heart failure, or cancer).

  • Patients with mental conditions which will affect understanding of the study protocol.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universiti Teknologi Mara

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noraini Binti Mohd Saad, Principal Investigator, Universiti Teknologi Mara
ClinicalTrials.gov Identifier:
NCT05736536
Other Study ID Numbers:
  • UiTMara Chance2Act
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 27, 2023