Weight LossNCT05928338
Lifestyle Modification for Weight Reduction With Peer Support Among Adults in an Urban Slum of Karachi, Pakistan
A study testing Peer-supported, WhatsApp-assisted lifestyle modification intervention in people with Weight Loss, run by Aga Khan University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Peer-supported, WhatsApp-assisted lifestyle modification intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Weight Loss
- Being tested
- Peer-supported, WhatsApp-assisted lifestyle modification intervention
- Keywords
- Lifestyle modification, Peer support, Weight reduction, Slums, WhatsApp, Mixed-methods
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-supported, WhatsApp-assisted lifestyle modification interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Peer-supported, WhatsApp-assisted lifestyle modification intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one year
Change in mean weight in kilograms
Trends of change in mean weight in kilograms was evaluated throughout the study
Measured: 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
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start15 Jul 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romaina Iqbal, Aga Khan University
- Investigators
- Romaina Iqbal, Ph.D, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928338
- Sponsor's protocol ID
- 2020-3550-9021
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37527890
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05928338
- Acronym / sponsor ID
- 2020-3550-9021
- Conditions
- Weight Loss
- Keywords
- Lifestyle modification, Peer support, Weight reduction, Slums, WhatsApp, Mixed-methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer-supported, WhatsApp assisted lifestyle modification intervention | Experimental | Behavioral: Peer-supported, WhatsApp-assisted lifestyle modification interventionStudy 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnancy
- Chronic conditions, disability, and other health-related issues that require special treatment and dietary and physical activity restrictions
- Males and females
- Aged 20 years and above
- Willing to attend online training sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-supported, WhatsApp-assisted lifestyle modification interventionThe 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. | Behavioural | Peer-supported, WhatsApp assisted lifestyle modification intervention |
Primary outcome
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
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
Change in mean weight in kilograms
Time frame: one year
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 37527890Naz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romaina Iqbal, Ph.D principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-supported, WhatsApp-assisted lifestyle modification intervention in people with Weight Loss, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants screened, recruited, retained, and responded to monthly interviews (time frame: one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05928338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.