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

NCT05260879 | Completed DMC

• 2 other identifiers: 2020/207/CE/FMOS/FAPH1R21TW011736-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Adoption of the recommended diet and exercise behavior

  Number of participant who adopt the DPP recommended diet and exercise behavior

  Month 0 to Month 6

Secondary Outcomes (3)

• Reduction in Body Mass Index (BMI)

  Month 0 to Month 6

• Reduction in number of participants with Hypertension

  Month 0 to Month 6

• Reduction in number of participants with hyperglycemia

  Month 0 to Month 6

Study Arms (3)

Individuals

EXPERIMENTAL

This arm is composed of diabetic or hypertensive men and women who participate without joint participation of their spouse. The intervention consists of exposing participants to bi-monthly educational sessions on diet and exercise. Participants will be organized in groups of 15 led by one community health worker (CHW) assisted by a diabetes peer educator (PE). The basic format for the group sessions will follow the pattern developed with the DPP program, beginning with a discussion of "success" stories from the past weeks before proceeding to the didactic portion of the session. The sessions will mix the didactic portions facilitated by the PE with group discussions, activities and role plays, facilitated by the CHW.

Behavioral: Diabetes prevention program

Couples

EXPERIMENTAL

Women recruited for the couples group will be asked to invite their husbands to participate, regardless of their husband's CVD status, and men whose wives do not have CVD similarly will be asked to enroll with their wife. The intervention consists in exposing them to bi-monthly educational sessions on diet and exercise. The intervention consists in exposing participants with bi-monthly educational sessions on diet and exercise. Participants will be organized in groups of 15 to 30, led by one community health worker (CHW) assisted by a diabetes peer educator (PE). The basic format for the group sessions will follow the pattern developed with the DPP program, beginning with a discussion of "success" stories from the past weeks before proceeding to the didactic portion of the session. The sessions will mix the didactic portions facilitated by the PE with group discussions, activities and role plays, facilitated by the CHW.

Behavioral: Diabetes prevention program

Comparison

NO INTERVENTION

The comparison group is composed of diabetic or hypertensive individuals who agreed to participate in the study but who will not be exposed to the sessions.

Interventions

Diabetes prevention program BEHAVIORAL

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

Also known as: PPD-Mali

Couples; Individuals

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 25 or more
• Diagnosed with type II diabetes or hypertension or Obesity
• Willing to commit to participate at biweekly sessions for 6 months

You may not qualify if:

• History of stroke or cardiac arrest
• Gestational diabetes
• Type I diabetes

Sponsors & Collaborators

• University Clinical Research Center, Mali: lead
• Columbia University: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (6)

ASACOBA

Bamako, Mali

Location

Asacodjeneka

Bamako, Mali

Location

ASACODOU

Bamako, Mali

Location

Asacola B5

Bamako, Mali

Location

Asacola Ii

Bamako, Mali

Location

Asacosisou

Bamako, Mali

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Seydou Doumbia, MD, PhD

  USTTB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: March 2, 2022
• Study Start: November 26, 2021
• Primary Completion: June 28, 2022
• Study Completion: April 30, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

MA (6)