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

Primary Purpose

Obesity, Diabetes Mellitus, Type 2, Behavior

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chance2Act
Sponsored by
Universiti Teknologi Mara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Changes of readiness to change for weight loss (behaviour)
    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

    Changes of self-efficacy for weight loss (behaviour)
    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
    Changes of decisional balance for weight loss (behaviour)
    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
    Changes in family support for healthy diet and physical activity to encourage weight loss (social support)
    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
    Changes body mass index (anthropometric)
    The changes body mass index measurement
    Changes waist circumference (anthropometric)
    The changes waist circumference measurement
    Changes in body fat composition (anthropometric)
    The changes in body fat composition (total and visceral fat)

    Full Information

    First Posted
    February 5, 2023
    Last Updated
    February 22, 2023
    Sponsor
    Universiti Teknologi Mara
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05736536
    Brief Title
    Behavior Intervention for Weight Loss for Type 2 Diabetes Mellitus Adults With Obesity Problem (BMI of ≥23kg/m2)
    Acronym
    BMI
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universiti Teknologi Mara

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Diabetes Mellitus, Type 2, Behavior

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    124 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    This group will receive the existing health education being offered in the health clinic.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Chance2Act
    Intervention Description
    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 Outcome Measure Information:
    Title
    Changes of readiness to change for weight loss (behaviour)
    Description
    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)
    Time Frame
    T0 (Week 0), T1 (Week 5), T2 (Week 9)
    Secondary Outcome Measure Information:
    Title
    Changes of self-efficacy for weight loss (behaviour)
    Description
    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
    Time Frame
    T0 (Week 0), T1 (Week 5), T2 (Week 9)
    Title
    Changes of decisional balance for weight loss (behaviour)
    Description
    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
    Time Frame
    T0 (Week 0), T1 (Week 5), T2 (Week 9)
    Title
    Changes in family support for healthy diet and physical activity to encourage weight loss (social support)
    Description
    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
    Time Frame
    T0 (Week 0), T1 (Week 5), T2 (Week 9)
    Title
    Changes body mass index (anthropometric)
    Description
    The changes body mass index measurement
    Time Frame
    T0 (Week 0), T1 (Week 5), T2 (Week 9)
    Title
    Changes waist circumference (anthropometric)
    Description
    The changes waist circumference measurement
    Time Frame
    T0 (Week 0), T1 (Week 5), T2 (Week 9)
    Title
    Changes in body fat composition (anthropometric)
    Description
    The changes in body fat composition (total and visceral fat)
    Time Frame
    T0 (Week 0), T1 (Week 5), T2 (Week 9)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    All data collected in the study will not be shared with other researchers to protect the confidentiality of patients' information as requested by the study site's authorized organization. The study IPD includes: Study Protocol Statistical Analysis Plan Informed Consent Form Clinical Study Report Analytic Code

    Learn more about this trial

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

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