Peer-modeled Intervention

NCT07476716 | Not Yet Recruiting DMC

• 1 other identifier: Peer-modeled
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the effects of a peer-led behavioural change intervention on the cardio-metabolic health of women aged 18 to 49 years. The main question it aims to answer is:

• Does a peer-led behavioural change intervention improve the cardio-metabolic health of women aged 18 to 49 years? Researchers will compare food literacy, physical literacy, and awareness with a comparison arm that receives only information on doable actions to improve cardio-metabolic health in a small booklet. The participants will:
• Participants in the intervention arm will have group activities on food literacy, physical literacy and awareness for 3 months of the active phase of the intervention.
• The participants in the intervention arm will be followed up with a phone call in between the active phase of the intervention.
• At the beginning of the study, the participants in the comparison arm will receive a small booklet with inforgraphics on ways to improve their cardio-metabolic health, with no further contact.
• All the participants will not be contacted in any form for the next 3 months after the active phase of the intervention.
• The participants will be measured for their waist circumference, fat mass, blood pressure, lipid and glucose levels, and arterial stiffness.
• The participants will also be assessed for physical activity levels, dietary intake, body size preferences, self-efficacy, social support, self-monitoring, and self-esteem.

Conditions

Cardio-metabolic Health

Keywords

Peer-modeled; behavioural; women; behavioural change; Uganda; cardio-metabolic; central adiposity

Outcome Measures

Primary Outcomes (1)

• Central adiposity

  Central adiposity will be assessed using a waist circumference of less than 80 cm. This is a cut-off based on the IDF guidelines for central adiposity and metabolic syndrome, a key parameter for cardio-metabolic health.

  At baseline, endline after 3 months of the study intervention's active phase, and at 6 months post-intervention.

Secondary Outcomes (12)

• Increase in physical activity levels

  Assessment at baseline, endline after 3 months of the intervention and at 6 months post-intervention.

• Increase in fruit and vegetable intake

  At baseline, 3 months at endline of the active phase of the intervention and at 6 months post-intervention

• Fasting blood glucose levels

  Measure at baseline, endline after 3 months of the intervention, and post-intervention at 6 months

• HDL cholesterol

  At baseline, after 3 months of the active phase of the intervention, and at 6 months post-intervention

• Triglycerides

  At baseline, after 3 months of the active phase of the intervention and at 6 months post-intervention.

Other Outcomes (7)

• Peer adherence

  At 6 months post-intervention

• Peer satisfaction

  At 6 months post-intervention

• Self-efficacy for physical activity

  At baseline, endline after 3 months of the intervention, and at the endline after 6 months post-intervention.

Study Arms (2)

Intervention arm

EXPERIMENTAL

This arm will have 77 participants. They will receive the 3 components of the behavioural intervention, including i) awareness, ii) physical literacy, and iii) food literacy. The awareness will include group discussion sessions and the use of info-graphics with information on cardio-metabolic health, cultural beauty perceptions, illustrations on the use of a waist circumference, and doable actions for optimal health. Physical literacy will include group sessions focused on increasing physical activity in daily life. Food literacy will include group sessions on food demonstrations, meal planning, food choices, the plate model, and information to increase intake of fruits and vegetables and reduce intake of fatty snacks.

Behavioral: A peer-modelled behavioural change intervention

A comparison arm

NO INTERVENTION

This arm will only receive a booklet with information and illustrations on benefits and recommendations for increasing fruit and vegetable intake and physical activity, as well as vegetable recipes and practical tips to eat more fruit and vegetables and engage in more physical activity. This booklet has already been published and utilised in a previous study within our study unit

Interventions

A peer-modelled behavioural change intervention BEHAVIORAL

This is a community-based intervention that uses a peer-modelled strategy. The intervention is termed a modelled intervention because its core mechanism is based on observational learning, whereby participants acquire new attitudes and behaviours by observing others who serve as models. In this study, the intervention specifically uses peer models, meaning individuals from the same social group demonstrate desirable attitudes and practices. The intervention uses three behavioural components of i) awareness of the health-beauty paradox and cardio-metabolic health; ii) physical literacy to increase daily physical activity through lifestyle; and iii) food literacy to increase the fruit and vegetable intake through better planning, access to food, food choices, food preparation, intake and information within the community.

Also known as: Community-based

Intervention arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women of reproductive age (WRA; 18 to 49 years).
• With central obesity measured as a waist circumference of \> 80cm and up to 88 cm.
• They should consent and be willing to follow a 3-month active intervention and a 3-month post-intervention follow-up.
• They should be residents of Mbarara City.
• They should either speak English or Runyakitara/Runyankore.

You may not qualify if:

• Pregnant and lactating for six months.
• Taking anti-diabetic or hypertension medication.
• Physically incapacitated to stand for measurements or speak

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Kakoba Health center 3

Mbarara, Western Region, 256, Uganda

Location

Related Publications (12)

• Rutterford C, Copas A, Eldridge S. Methods for sample size determination in cluster randomized trials. Int J Epidemiol. 2015 Jun;44(3):1051-67. doi: 10.1093/ije/dyv113. Epub 2015 Jul 13.

  PMID: 26174515 BACKGROUND

• Parati G, De Buyzere M. Evaluating aortic stiffness through an arm cuff oscillometric device: is validation against invasive measurements enough? J Hypertens. 2010 Oct;28(10):2003-6. doi: 10.1097/HJH.0b013e32833f0e93. No abstract available.

  PMID: 20844367 BACKGROUND

• Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.

  PMID: 25791983 BACKGROUND

• McCarthy CP, Bruno RM, McEvoy JW, Touyz RM. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension: what is new in pharmacotherapy? Eur Heart J Cardiovasc Pharmacother. 2025 Feb 8;11(1):7-9. doi: 10.1093/ehjcvp/pvae084. No abstract available.

  PMID: 39439212 BACKGROUND

• Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.

  PMID: 23159157 BACKGROUND

• Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS. Self-efficacy in weight management. J Consult Clin Psychol. 1991 Oct;59(5):739-44. doi: 10.1037//0022-006x.59.5.739.

  PMID: 1955608 BACKGROUND

• Bull FC, Maslin TS, Armstrong T. Global physical activity questionnaire (GPAQ): nine country reliability and validity study. J Phys Act Health. 2009 Nov;6(6):790-804. doi: 10.1123/jpah.6.6.790.

  PMID: 20101923 BACKGROUND

• Alberti KG, Zimmet P, Shaw J. Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet Med. 2006 May;23(5):469-80. doi: 10.1111/j.1464-5491.2006.01858.x.

  PMID: 16681555 BACKGROUND

• Yiga P, Seghers J, Ogwok P, Matthys C. Determinants of dietary and physical activity behaviours among women of reproductive age in urban sub-Saharan Africa: a systematic review. Br J Nutr. 2020 Oct 28;124(8):761-772. doi: 10.1017/S0007114520001828. Epub 2020 May 28.

  PMID: 32460934 BACKGROUND

• Yiga P, Ogwok P, Achieng J, Auma MD, Seghers J, Matthys C. Determinants of dietary and physical activity behaviours among women of reproductive age in urban Uganda, a qualitative study. Public Health Nutr. 2021 Aug;24(12):3624-3636. doi: 10.1017/S1368980020003432. Epub 2020 Oct 1.

  PMID: 33000718 BACKGROUND

• Yiga P, Mokaya M, Kiyimba T, Ogwok P, Kyallo F, Koole JL, Boedt T, Matthys C. Measurement of food literacy among the adult population in urban Uganda and Kenya: development and validation of an East African food literacy scale. Public Health Nutr. 2024 Sep 23;27(1):e171. doi: 10.1017/S136898002400168X.

  PMID: 39310997 BACKGROUND

• Yiga P, Van der Schueren B, Seghers J, Kiyimba T, Ogwok P, Tafiire H, Muluta SN, Matthys C. Effect of a complex lifestyle intervention to optimize metabolic health among females of reproductive age in urban Uganda, a randomized controlled trial. Am J Clin Nutr. 2023 Feb;117(2):436-443. doi: 10.1016/j.ajcnut.2022.12.005. Epub 2022 Dec 23.

  PMID: 36811566 BACKGROUND

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christophe Matthys, Doctorate

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Grace Muhoozi, Doctorate

  Kyambogo University, Kampala

  STUDY DIRECTOR

Central Study Contacts

Christophe Matthys, Doctorate

CONTACT

+3216342655; christophe.matthys@uzleuven.be

Monicah Agaba, Masters

CONTACT

+256778841758; monicah.agaba@student.kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The peer models who will deliver the intervention in the community.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study includes intervention and comparison arms that are run concurrently across different clusters. Hence, a cluster randomised controlled trial.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IDP and supporting information will be available three months in advance of the request, and that is also after article publication. It will be available for 10 years.
• Access Criteria: Access will be granted to researchers with methodologically sound proposals upon request, by contacting the principal investigator, who will lead the approval process. The researcher will be given access to the KU Leuven data repository to access the requested data files only.

Locations

UG (1)