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Completed

NCT Number: NCT05736536

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

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?

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Key information

Conditions

Obesity Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beserah Health Clinic, Kuantan, Pahang, Malaysia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chance2Act

Behavioral

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.

Primary outcomes

  1. Changes of readiness to change for weight loss (behaviour)

    Time frame: 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 outcomes

  1. Changes of self-efficacy for weight loss (behaviour)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: T0 (Week 0), T1 (Week 5), T2 (Week 9)

    The changes body mass index measurement

  5. Changes waist circumference (anthropometric)

    Time frame: T0 (Week 0), T1 (Week 5), T2 (Week 9)

    The changes waist circumference measurement

  6. Changes in body fat composition (anthropometric)

    Time frame: T0 (Week 0), T1 (Week 5), T2 (Week 9)

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

Sponsors and collaborators

Lead sponsor

Universiti Teknologi Mara

Other

Registry information

Official study 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

Acronym: BMI

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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