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Lifestyle Modification for Weight Reduction With Peer Support Among Adults in an Urban Slum of Karachi, Pakistan

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Peer-supported, WhatsApp-assisted lifestyle modification intervention
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Weight Loss focused on measuring Lifestyle modification, Peer support, Weight reduction, Slums, WhatsApp, Mixed-methods

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Participants: Males and females Aged 20 to 60 years Had access to smartphones and an internet connection Agreed to nominate one peer from their family Provide written informed consent Exclusion Criteria for Participants: Pregnancy Chronic conditions, disability, and other health-related issues that require special treatment and dietary and physical activity restrictions Eligibility Criteria for Peers: Males and females Aged 20 years and above Willing to attend online training sessions Agreed to help participants with lifestyle modification adherence throughout the study Provide written informed consent

Sites / Locations

  • Sabahat Naz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peer-supported, WhatsApp assisted lifestyle modification intervention

Arm Description

Study participants with BMI 23 kg/m2 and above was provided with a lifestyle modification intervention supported by peers for modifying their diet and increase physical activity to reduce weight

Outcomes

Primary Outcome Measures

Number of participants screened, recruited, retained, and responded to monthly interviews
The feasibility of the study was evaluated by reporting number of participants screened, recruited, retained, and responded to monthly interviews
Barriers, facilitators, acceptability, and experience of participants and peers to lifestyle modification intervention through in-depth interviews
In-depth interviews were conducted at the end of the study to explore barriers, facilitators, acceptability, and experience of participants and peers about lifestyle modification intervention for weight reduction
Change in mean weight in kilograms
Trends of change in mean weight in kilograms was evaluated throughout the study
Change in mean calorie intake (kcal/day) from food using 24-hour dietary recall
Trends of change in mean calorie intake (kcal/day) from food using 24-hour dietary recall was evaluated throughout the study
Change in mean calorie expenditure (kcal/day) through physical activity using Global Physical Activity questionnaire (GPAQ)
Trends of change in mean calorie expenditure (kcal/day) through physical activity using Global Physical Activity questionnaire (GPAQ) was evaluated throughout the study

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
June 23, 2023
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT05928338
Brief Title
Lifestyle Modification for Weight Reduction With Peer Support Among Adults in an Urban Slum of Karachi, Pakistan
Official Title
Feasibility of a Peer-Supported, WhatsApp-Assisted, Lifestyle Modification Intervention for Weight Reduction Among Adults in an Urban Slum of Karachi, Pakistan: A Mixed-Methods, Single Group, Pretest-Posttest, Quasi-Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

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

5. Study Description

Brief Summary
The feasibility study was conducted using a mixed-methods single group, pre and post-test design (Quasi experiment) approach. The investigator assessed if a weight reduction program using WhatsApp and peer support would work well enough to conduct a larger study. The investigator conducted the study in an urban slum (Azam Basti) in Karachi, Pakistan and enrolled 50 participants, along with participant nominated peers from the same family. Initial eligibility was assessed over the phone. Those who met the initial eligibility were visited to assess eligibility in terms of BMI (23 kg/m2 and above). Height was measured in centimeters (cm) and weight in kilograms (kgs) using a digital weighing scale. Both values were entered into the web-based calculator to calculate BMI. Participants with a BMI of 23 kg/m2 and above were enrolled and written informed consent was obtained. The participants then nominated one peer from the family. Peer eligibility was assessed and written informed consent was obtained. Once the participants and peers were enrolled in the study, the baseline assessments were completed. During the baseline assessments, participants were interviewed for sociodemographic and health-related information, 24-hour dietary recall, and Global Physical Activity Questionnaire (GPAQ). Peers were also interviewed for sociodemographic information. After the baseline assessment, the participants and peers received lifestyle modification education through WhatsApp voice calls for three days and then once monthly for one year delivered by a trained nutritionist. The intervention was delivered mostly in groups. The peer-supported lifestyle modification intervention was developed with the aim of helping participants adopt healthier lifestyles by making dietary changes, increasing physical activity, and achieving a weight loss goal of 5% of their initial body weight. Additionally, the intervention aimed to prevent weight gain among participants. The participants were followed-up for one year. Participants weight (kg), diet through 24-hour dietary recall, and physical activity through Global Physical Activity Questionnaire (GPAQ) were assessed every month. Social support questionnaire was also asked from participants at 3, 6, 9, and 12 months. The investigator also conducted in-depth interviews at the end of the study with study participants and peers to understand the barriers, facilitators, and experiences of the lifestyle modification intervention program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Lifestyle modification, Peer support, Weight reduction, Slums, WhatsApp, Mixed-methods

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer-supported, WhatsApp assisted lifestyle modification intervention
Arm Type
Experimental
Arm Description
Study participants with BMI 23 kg/m2 and above was provided with a lifestyle modification intervention supported by peers for modifying their diet and increase physical activity to reduce weight
Intervention Type
Behavioral
Intervention Name(s)
Peer-supported, WhatsApp-assisted lifestyle modification intervention
Intervention Description
The lifestyle modification intervention, supported by peers and WhatsApp voice calls aimed to assist participants in making dietary modifications, increasing physical activity, and achieve a weight loss of 5% of their initial body weight as well as avoid weight gain. A trained nutritionist delivered the intervention after the baseline assessment individually or in groups that covered six sessions related to dietary modifications, physical activity, set-up goals and action plans, and peer assignments and then once monthly for a year using WhatsApp voice calls to the participants and peers.
Primary Outcome Measure Information:
Title
Number of participants screened, recruited, retained, and responded to monthly interviews
Description
The feasibility of the study was evaluated by reporting number of participants screened, recruited, retained, and responded to monthly interviews
Time Frame
one year
Title
Barriers, facilitators, acceptability, and experience of participants and peers to lifestyle modification intervention through in-depth interviews
Description
In-depth interviews were conducted at the end of the study to explore barriers, facilitators, acceptability, and experience of participants and peers about lifestyle modification intervention for weight reduction
Time Frame
one year
Title
Change in mean weight in kilograms
Description
Trends of change in mean weight in kilograms was evaluated throughout the study
Time Frame
one year
Title
Change in mean calorie intake (kcal/day) from food using 24-hour dietary recall
Description
Trends of change in mean calorie intake (kcal/day) from food using 24-hour dietary recall was evaluated throughout the study
Time Frame
one year
Title
Change in mean calorie expenditure (kcal/day) through physical activity using Global Physical Activity questionnaire (GPAQ)
Description
Trends of change in mean calorie expenditure (kcal/day) through physical activity using Global Physical Activity questionnaire (GPAQ) was evaluated throughout the study
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Participants: Males and females Aged 20 to 60 years Had access to smartphones and an internet connection Agreed to nominate one peer from their family Provide written informed consent Exclusion Criteria for Participants: Pregnancy Chronic conditions, disability, and other health-related issues that require special treatment and dietary and physical activity restrictions Eligibility Criteria for Peers: Males and females Aged 20 years and above Willing to attend online training sessions Agreed to help participants with lifestyle modification adherence throughout the study Provide written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romaina Iqbal, Ph.D
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sabahat Naz
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

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Lifestyle Modification for Weight Reduction With Peer Support Among Adults in an Urban Slum of Karachi, Pakistan

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