Potential Effectiveness of the Diabetes Prevention Program in the Peri-urban Area of Bamako, Mali
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 6
- 主要终点
- Adoption of the recommended diet and exercise behavior
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 25 or more
- •Diagnosed with type II diabetes or hypertension or Obesity
- •Willing to commit to participate at biweekly sessions for 6 months
排除标准
- •History of stroke or cardiac arrest
- •Gestational diabetes
- •Type I diabetes
结局指标
主要结局
Adoption of the recommended diet and exercise behavior
时间窗: Month 0 to Month 6
Number of participant who adopt the DPP recommended diet and exercise behavior
次要结局
- Reduction in number of participants with Hypertension(Month 0 to Month 6)
- Reduction in number of participants with hyperglycemia(Month 0 to Month 6)
- Reduction in Body Mass Index (BMI)(Month 0 to Month 6)