- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05928338
Lifestyle Modification for Weight Reduction With Peer Support Among Adults in an Urban Slum of Karachi, Pakistan
June 23, 2023 updated by: Romaina Iqbal, Aga Khan University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Karachi, Pakistan, 74800
- Sabahat Naz
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer-supported, WhatsApp assisted lifestyle modification intervention
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants screened, recruited, retained, and responded to monthly interviews
Time Frame: one year
|
The feasibility of the study was evaluated by reporting number of participants screened, recruited, retained, and responded to monthly interviews
|
one year
|
|
Barriers, facilitators, acceptability, and experience of participants and peers to lifestyle modification intervention through in-depth interviews
Time Frame: one year
|
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
|
one year
|
|
Change in mean weight in kilograms
Time Frame: one year
|
Trends of change in mean weight in kilograms was evaluated throughout the study
|
one year
|
|
Change in mean calorie intake (kcal/day) from food using 24-hour dietary recall
Time Frame: one year
|
Trends of change in mean calorie intake (kcal/day) from food using 24-hour dietary recall was evaluated throughout the study
|
one year
|
|
Change in mean calorie expenditure (kcal/day) through physical activity using Global Physical Activity questionnaire (GPAQ)
Time Frame: one year
|
Trends of change in mean calorie expenditure (kcal/day) through physical activity using Global Physical Activity questionnaire (GPAQ) was evaluated throughout the study
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Romaina Iqbal, Ph.D, Aga Khan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2020
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
June 14, 2023
First Submitted That Met QC Criteria
June 23, 2023
First Posted (Actual)
July 3, 2023
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 23, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-3550-9021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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