Potential Effectiveness of the Diabetes Prevention Program in the Peri-urban Area of Bamako, Mali

NCT05260879 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2023-12-27

No results posted yet for this study

Summary

The proposed research is an innovative adaptation of the Centers for Disease Control and Prevention's (CDC) Diabetes Prevention Program "Power to Prevent" program, which will be developed and piloted in the low-income peri-urban neighborhoods of Bamako, Mali. This program is well-suited to delivery by the city's community health workers already supporting families in improving maternal and child health outcomes. First, it will use participatory research methods to engage them and community residents in making adaptations to the community health worker's guidelines and tools for recommended activities so that they are linguistically and culturally appropriate, including guidelines for food consumption using locally available foods. These adaptations will use more graphics and photographs, so they are appropriate for low-literacy participants. Second, another key innovation is the explicit orientation to couples, where only one may have a diagnosed cardiovascular disease. This adaptation will provide tools the women can use in negotiating for changes to the family's meals and her daily routine. Third, investigators will conduct a comparative effectiveness study at 6 community health centers with high rates of Cardiovascular Disease (CVD), recruiting adults recently diagnosed with diabetes or hypertension. Based on the random allocation of their community health center, participants will be assigned to one of three groups of 150 each: Couples, with at least one meeting the eligibility criteria; Individuals, men and women, both eligible; Comparison, men and women with CVD. Trained community health workers and diabetic peer educators will use the adapted Diabetes Prevention Program (DPP) materials with the Couples and Individuals groups over a period of 6 months. At the conclusion of this pilot investigators will assess the levels of adoption of recommended cardiovascular risk reduction behaviors and changes in obesity, hypertension, and diabetes control, comparing differences in outcomes between the three groups. It will enable Mali to incorporate diabetes and hypertension risk reduction into their already deployed networks of community health workers. The Malian DPP adaptation will also be suitable for Francophone West Africa, where customs and lifestyles are similar among the millions of families confronting the burdens of cardiovascular disease.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Diabetes prevention program

Adaptation of the Centers for Disease Control and Prevention (CDC) Diabetes Prevention Program Power to Prevent for use in low income neighborhoods in Bamako, Mali

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER
  • Fogarty International Center of the National Institute of Health

    collaborator NIH
  • University Clinical Research Center, Mali

    lead OTHER

Principal Investigators

  • Seydou Doumbia, MD, PhD · USTTB

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-26
Primary Completion
2022-06-28
Completion
2023-04-30

Countries

  • Mali

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05260879 on ClinicalTrials.gov