Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05260879 |
| Other study ID # |
2020/207/CE/FMOS/FAPH |
| Secondary ID |
1R21TW011736-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 26, 2021 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
University Clinical Research Center, Mali |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Specific Aims:
Aim 1 will adapt the diet and lifestyle change modalities of the Small Steps, Big Rewards
(SSBR) recommendations to the cultural and economic realities affecting women's choices in
Bamako. As in other cross-national adaptations of the DPP, investigators will translate the
food and exercise recommendations into equivalent recommendations using locally available
foods and exercise opportunities. Study partners have already estimated the caloric and
glycemic indices of the most common foods prepared in Mali, and the demonstrations and
recommendations will be based on these estimations. Cultural and gender-sensitive
recommendations for exercise will be similarly tailored to the urban African context, with
participating women from the low-income communities ensuring the cultural appropriateness of
these adaptations.
Aim 2 will develop culturally and gender-specific communication strategies for empowering
low- income, low-literacy women to apply the SSBR recommendations for themselves and their
families. Investigators will incorporate the tools and demonstrations for SSBR developed in
Aim 1 to the refinement of the Malian adaptation SSBR-Mali group sessions. An effective
approach to chronic disease management in Africa has promoted sharing adherence messages
among couples, so they can better support each other in staying adherent. The preliminary
work also highlights the need to explore alternative methods to help women gain the approval
and support of their spouses and other family members.
Aim 3 is to assess the effectiveness of the Malian adaptation of the DPP to increase adoption
of diabetes prevention practices and reduce hyperglycemia and hypertension among couples
enrolling in the program, compared to those participating as individuals. Using the
adaptation developed in Aim 2 the investigators will compare the effectiveness of the Malian
adaptation of the SSBR in selected community health centers in peripheral low-income
communities with high rates of diabetes or hypertension. Trained CHWs and diabetic peer
educators will implement the program for 6 months, with assessments conducted to compare
changes pre-post participation in healthy behaviors and diabetes and hypertension management
outcomes with 450 participants in the intervention at 4 community health centers versus 150
comparable individuals at 2 control community centers. The analysis will focus on the
comparison of effectiveness for individuals enrolled as couples where at least one has CVD
versus those enrolled as individuals with CVD.
Research Plan
A. Innovation
The couple-orientation to this DPP is innovative, as all previous DPP adaptations focus on
individual participants. By enrolling both members of a couple where only one of them may
have diabetes or hypertension, they will both participate in group sessions and learn how
they can support each other to make changes. Carefully crafted role plays will provide women
with the communication tools for negotiating changes to family meals or daily activities. The
adaptation will be the first which recognizes the need for materials to be appropriate for
low-literacy participants, with greater use of locally prepared photographic and graphic
content for group sessions, the CHW flip-chart and participant food and activity tracker
materials. The participatory approach to developing the pilot study will further strengthen
the skills of the University of Sciences, Techniques and Technologies of Bamako (USTTB)
researchers toward shifting their research out of the clinics and into the neighborhoods,
enabling them to better partner with the health ministry as they move in the direction of
prevention and community-based health services.
B. Approach
1. Study Site: Mali has noncommunicable diseases mortality rates among the highest in the
world and higher for women than men. In 2019, the number of adults with diabetes was
estimated at 157,600 adults, with only 50,000 aware of their diabetes. Bamako, the
capital city with over 2 million residents, has the highest obesity and cardiovascular
disease rates. Over one in ten urban adults are diabetic, and one in four hypertensive.
Between 2002 and 2013 obesity among city residents aged 15-65 rose from 10% to 16%, with
obesity rates five times higher for women than men. The rates of obesity and
malnutrition (low diet diversity) were higher among the less educated and in low-income,
peripheral neighborhoods. Therefore, this pilot study will focus on the low-income
peripheral neighborhoods of Communes I and IV, where the investigators will select the
six Community Health Centers (CSCOM), Mali's primary health care centers, with the
highest numbers of diabetes and hypertension diagnoses in the previous two years. Four
will be randomly selected to participate in the pilot, while two will serve as
comparison sites.
2. Research Strategy The adaptation of the DPP SSBR program will adhere to the principles
of the trans-theoretical model for facilitating behavioral change to resistant
behaviors. The group lifestyle behavior approach of the DPP program is already based on
the principles of the trans-theoretical change model, with the sessions helping people
move quickly from pre-contemplation to contemplation (Sessions 1 and 2), preparation
(Sessions 3-6), with adoption the focus of sessions 4-9, and maintenance the focus of
sessions 10-12. The role plays, demonstrations, and discussions are designed to build
the confidence of women to introduce healthy eating and lifestyles to their husbands and
other women in their household. To ensure that the tools and activities are appropriate
for the Bamako context, participatory research methods will be used, inviting 30
community residents (12 women, 12 men and 6 CHWs) from the a CSCOM to participate in the
adaptation process.
To make the sessions more culturally appropriate, including the importance of involving the
other women in the household in food and cooking decisions, the investigators have added
sessions on how to share the responsibility for a healthy lifestyle with the other women in
the household, as well as how to gain the support of the household head and other family and
friends. The sessions on eating out and reading labels have been modified to be appropriate
for the types of street food and market products available in Bamako. The sessions on caloric
balance have been converted to the balance in the number of portions, with an emphasis on
measuring portions and ingredients used in cooking. Role plays, demonstrations, and videos of
exercises have been included, complementing the group discussions already included in the DPP
group approach format. With these additions the number of sessions is 15, similar to that
used in other group lifestyle adaptations of the DPP Power to Prevent. The training tools
were pre-tested with the community health workers of a CSCOM in Bamako, and then finalized
during the training of the community health workers who will deliver the program.
After the SSBR-M sessions and tools are developed, a pilot study will be conducted to assess
the potential contribution that participation might make to changes in recommended behaviors
of the participants and their spouses, as well as to their level of blood sugar, blood
pressure, BMI and waist circumference.
