NCT05928338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

June 14, 2023

Last Update Submit

June 23, 2023

Conditions

Keywords

Lifestyle modificationPeer supportWeight reductionSlumsWhatsAppMixed-methods

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • Change in mean weight in kilograms

    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

    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)

    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

Study Arms (1)

Peer-supported, WhatsApp assisted lifestyle modification intervention

EXPERIMENTAL

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

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

Interventions

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.

Peer-supported, WhatsApp assisted lifestyle modification intervention

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sabahat Naz

Karachi, 74800, Pakistan

Location

Related Publications (1)

  • Naz S, Haider KA, Jaffar A, Khan U, Azam I, Siddiqui AR, Iqbal R. 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-post-test, quasi-experimental study. BMJ Open. 2023 Aug 1;13(8):e070913. doi: 10.1136/bmjopen-2022-070913.

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Romaina Iqbal, Ph.D

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Section Head Non-Communicable Diseases and Mental Health

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 3, 2023

Study Start

July 15, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations