Peer-modeled Intervention

ConditionCardio-metabolic Health

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-49

SponsorKU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant and lactating for six months.

Taking anti-diabetic or hypertension medication.

Physically incapacitated to stand for measurements or speak

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

157 Participants

are divided into 2 treatment groups

Group A: Intervention armExperimental treatment 1 intervention

Group B: A comparison armNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Increase in physical activity levels

The participants' physical activity levels will be assessed using the Global Physical Activity Questionnaire. Physical activity levels of \< 600 metabolic equivalents to task (METs) will serve as the reference for physical inactivity associated with sub-optimal cardio-metabolic health.

Time frame

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

Increase in fruit and vegetable intake

The fruit and vegetable servings will be converted to grams using WHO guidelines and calculations. The calculated grams will be categorised into those below 400 g or above the minimum recommended daily intake of \>400 g.

Time frame

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

Fasting blood glucose levels

Through a finger prick, blood will be collected to assess the fasting glucose levels. Fasting blood glucose levels will be assessed using a CardioCheck Plus. Fasting blood glucose levels of \< 100mg/dl will be the reference for optimal health.

Time frame

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

HDL cholesterol

A finger prick will be used to obtain blood for HDL cholesterol measurement. A cholesterol meter will be used to measure the HDL cholesterol levels. A reading of \> 50 mg/dl will be the reference for optimal cardio-metabolic health.

Time frame

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

Other outcomes

Peer adherence

The investigators will conduct a process evaluation to assess participants' adherence to the intervention by reviewing their waist circumference records per session. Out of the planned 9 sessions, participants will be categorised into tertiles as having high, medium, or low adherence.

Time frame

At 6 months post-intervention

Peer satisfaction

Assessment of content satisfaction will be based on the following factors: time, place for peer sessions, module objectives, content, structure, relevance and leadership. A Likert scale with scores ranging from 1 (strongly disagree) to 5 (strongly agree) will be used. With a maximum score of 50 points, each factor's total score will be transformed into a percentage, and the total percentage obtained. A higher score indicates higher satisfaction.

Time frame

At 6 months post-intervention

Self-efficacy for physical activity

Self-efficacy will be assessed in terms of its interaction with the intervention and its effect on the intervention's effectiveness. Self-efficacy for physical activity will be measured with a 10-item Likert self-efficacy for exercise behaviours scale. With a scale of 1 (Not always true) to 4 (Always true). Based on the average score, participants will be assessed regarding their increase on a scale of 1 to 4, where a higher score indicates increased self-efficacy for better behavioural outcomes.

Time frame

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

Self-efficacy for dietary intake

Using a 5-item questionnaire, self-efficacy for dietary change will be assessed. The Likert scale uses a score from 1 (Not always true) to 4 (Always true). Self-efficacy will be scored based on changes in the average score, ranging from 1 to 4. Where 1 is the lowest, and 4 is the highest score. The highest score indicates greater self-efficacy associated with improved behavioural outcomes.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KU Leuven

Lead sponsor

Source ClinicalTrials.gov

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