About this trial
This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Family 1.a.) Black Parent/Guardian: age 18 years or older residing in the same household with child (i.e., biological or have legal guardianship for child) 1.b.) Child: age 8-15 years old
Parent/Guardian have HbA1c level 5.7-6.4% (prediabetes)
Parent/Guardian willing to commit to participation in a 20-month research study and have no plans to move from the area over the next 20-months
Parent/child are ambulatory and able to participate in physical activity
Disqualifiers
Individuals with severe psychological disorders that may prevent/interfere with study participation
Physical impairments that may prevent participation in moderate intensity physical activity;
Previous diagnosis of diabetes
History of congestive heart failure, renal failure, or recent (<12 months) cardiovascular events such as myocardial infarction or stroke;
Trial design
Single group
Treatments tested in this trial
Families Implementing Good Health Traditions for Life
BehavioralThe 16-session weekly curriculum will have five components: 1) strategies for monitoring food intake and reducing calories; 2) identifying and controlling both personal and social cues for unhealthy eating behaviors; 3) the role of stress in unhealthy eating and relapse prevention; 4) strategies for monitoring and improving physical activity and sedentary behaviors; and 5) strategies to improve family support and cohesion. Parents and children will be divided into separate, 2-hour sessions most weeks. The sessions will be co-facilitated by trained CHWs and research staff members. As children of different ages will be participating, enough staff will be present to keep youth sessions well-coordinated in order to engage all ages. All sessions will be held in community locations convenient to the families, such as YMCAs, faith-based institutions, federally qualified health centers, etc.
Treatment groups
Trial outcomes
Primary outcomes
Change in weight from baseline to post-intervention at 4 months
Parents enrolled in the family intervention will demonstrate a 4% change in weight at the end of the intervention.
Sponsors and contacts
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Morehouse School of Medicine
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator