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

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05928338
• Other study ID #: 2020-3550-9021
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: June 2023
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Behavioral:
• Peer-supported, WhatsApp-assisted lifestyle modification intervention
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.

Locations

Country	Name	City	State
Pakistan	Sabahat Naz	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year
Primary	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	one year
Primary	Change in mean weight in kilograms	Trends of change in mean weight in kilograms was evaluated throughout the study	one year
Primary	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	one year
Primary	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	one year