Diabetes Prevention Through Genetics, Familial History and Behavior Change
Legacy-DPP: Diabetes Prevention Through Genetics, Familial History and Behavior Change A Family-Enhanced, Genetically-Informed Diabetes Prevention Program
The goal of this clinical trial is to learn if adding a family engagement component to the standard Diabetes Prevention Program (DPP) improves outcomes for adults with prediabetes. It will also learn about the effects of this approach on family members' health.
The main questions it aims to answer are:
- Does adding family health history collection and family participation to the DPP improve session attendance compared to standard DPP?
- Does this family-centered approach lead to greater weight loss and HbA1c (blood sugar) reduction compared to standard DPP?
- Do health improvements extend to participants' family members, and what factors explain differences in family-level outcomes?
Researchers will compare an adapted DPP with a family component to the standard DPP (individual-focused) to see if involving family members improves diabetes prevention outcomes.
Participants will:
- Be assigned to one of two groups: adapted DPP with family sessions, or standard DPP
- If assigned to the adapted DPP, complete a family health history using the CDC's My Family Health Portrait tool and attend 6 additional sessions with family members focused on personalized risk communication
- Attend regular checkups to measure weight and HbA1c at 6 and 12 months
- Have session attendance tracked throughout the program
- Family members of participants may also be asked to complete health assessments to measure any changes in their own health behaviors
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Type 2 diabetes affects 38.4 million U.S. adults, and an additional 97.6 million adults have prediabetes and are at risk of developing the disease. This burden falls disproportionately on racial and ethnic minority families and rural communities.
This clinical trial aims to determine whether embedding family engagement and family health history into the Diabetes Prevention Program (DPP) improves adherence, weight loss, and glycemic outcomes among adults with prediabetes, compared to the standard individual-focused DPP.
Participants will be 200 index participants with prediabetes, along with their family members, recruited from rural and urban sites and stratified by geographic location. Index participants will be block randomized to receive either standard DPP or an adapted version that adds 6 weeks of family health history and genetics education-using the CDC's My Family Health Portrait tool-paired with family participation and skill-building sessions.
All participants will attend regular clinic visits to monitor weight and HbA1c at 6 and 12 months and will have session attendance tracked throughout. Family members will also complete health assessments to measure whether health improvements extend beyond the index participant, and researchers will use the Actor-Partner Interdependence Model to identify factors explaining variation in family-level outcomes.
This is a 2-arm randomized controlled trial comparing standard DPP to a family-adapted DPP incorporating family health history, genetics education, and family skill-building.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Tennille Leak-Johnson, PhD
- Telefoonnummer: 404-756-5225
- E-mail: tleakjohnson@msm.edu
Studie Contact Back-up
- Naam: Candice L Alick, PhD
- Telefoonnummer: 404-752-1009
- E-mail: calick@msm.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Age ≥18 years.
- Fasting HbA1c 5.7-6.4% confirmed by CLIA-waived point-of-care testing.
- BMI ≥25 kg/m².
- Able to provide informed consent.
- Has an adult household/family or framily (fictive kin) member willing to enroll as a paired participant.
- Willing to attend in-person sessions
Exclusion Criteria:
- Minors <18 years
- Prior diagnosis of T1 or T2D.
- HbA1c ≥6.5% at screening (Aim 1/2 curriculum eligibility)
- Current glucose-lowering medication use
- Pregnancy
- Physical-activity contraindications
- Individuals unable to speak or understand English
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Lifestyle Engagement through Genetics and Collaborative familY DPP (LEGACY DPP)
Participants will receive the LEGACY DPP intervention
|
The index partner will participate in an adapted DPP as a dyad with a family member with family health history and family participation and skill building Participants will receive
|
|
Actieve vergelijker: Diabetes Prevention Program (DPP)
Participants will receive the DPP intervention
|
The index partner will participate in standard DPP Participants will receive - core behavioral weight loss group sessions |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percent change in body weight
Tijdsspanne: Baseline, 6 months, 12 months
|
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
|
Baseline, 6 months, 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean Change in Blood Pressure
Tijdsspanne: Baseline, 6 months, 12 months
|
Blood Pressure measured after 5 minutes of rest and taken in the same position throughout the study.
|
Baseline, 6 months, 12 months
|
|
Change in HbA1c (fasting, CLIA-waived assay)
Tijdsspanne: Baseline, 6 months, 12 months
|
Blood (~20 mL) will be collected to assess changes in glycosloated hemoglobin
|
Baseline, 6 months, 12 months
|
|
Change in Fasting lipid panel (total cholesterol, HDL, LDL, triglycerides)
Tijdsspanne: Baseline, 6 months, 12 months
|
Fasting lipid panel will measured to assess changes in total cholesterol, HDL, LDL, and triglycerides.
|
Baseline, 6 months, 12 months
|
|
Change in Skin carotenoids
Tijdsspanne: Baseline, 6 months, 12 months
|
Skin carotenoids will be assessed using a VeggieMeter as an indicator for fruit and vegetable intake.
|
Baseline, 6 months, 12 months
|
|
Change in Physical activity steps
Tijdsspanne: Baseline, 6 months, 12 months
|
Steps will be measured using an activity tracker e.g., Fitbit
|
Baseline, 6 months, 12 months
|
|
Change in Self-Regulation of Eating Behaviors
Tijdsspanne: Baseline, 6 months, 12 months
|
The Eating Behavior Inventory (20 items) measures the adoption of eating behaviors associated with weight loss (e.g., monitoring quantity eaten, frequency of weighing, shopping from a list) to measure self-regulation behaviors.
Items are rated on a 5-point frequency scale from "never or hardly ever" to "always or almost always."
Scores range from 26 to 130
|
Baseline, 6 months, 12 months
|
|
Change in Self-Efficacy of Eating Behaviors
Tijdsspanne: Baseline, 6 months, 12 months
|
Measured by survey responses to the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF).Scale goes from 0 (not at all confident) to 10 (very confident).
Higher scores mean better self efficacy.
|
Baseline, 6 months, 12 months
|
|
Change in Self-Efficacy of Physical Activity
Tijdsspanne: Baseline, 6 months, 12 months
|
The confidence subscale of the Patient-centered Assessment and Counseling for Exercise Adult Diet and Physical Activity Measure (6 items; ) measures confidence in participating in regular exercise or physical activity in different situations (e.g., "How confident are you that you would participate in regular exercise or physical activity: When I am tired?").
Items rated on a scale from 1 ("not at all confident") to 6 ("extremely confident").
Higher scores show higher self-efficacy.
|
Baseline, 6 months, 12 months
|
|
Change in Social Support for Eating
Tijdsspanne: Baseline, 6 months, 12 months
|
The Social Support and Eating Habits Survey (10 items) measures social support specific to healthy eating.
Subscales assess encouragement for eating behaviors from partners (e.g., "Encouraged me not to eat 'unhealthy food' when I am tempted") and discouragement for eating behaviors from partners (e.g., "Brought home foods I am trying not to eat").
The items are rated on a scale of "none" to "very often."
Total scores range from 5 to 50, with higher scores indicating more social support for eating behaviors.
|
Baseline, 6 months, 12 months
|
|
Change in Social Support for Exercise
Tijdsspanne: Baseline, 6 months, 12 months
|
The exercise participation subscale of the Social Support and Exercise Survey (10 items) measures social support specific to exercise behaviors.
The subscale assesses the level of support for exercise from partners.
Subscale example items include "Exercised with me" and "Criticized or made fun of me for exercising."
Total scores range from 5 to 50, with higher scores indicating more social support for exercise participation behaviors.
|
Baseline, 6 months, 12 months
|
|
Change in Family Communication
Tijdsspanne: Baseline, 6 months, 12 months
|
Family communication is assessed with the communication subscale of the McMaster Family Assessment Device (6 items).
Communication is defined as the exchange of information among family members.
Items focused on whether verbal messages were clear and direct for the intended recipient.
Responses ranged from "strongly agree" to "strongly disagree."
Higher scores represent unhealthy communication.
|
Baseline, 6 months, 12 months
|
|
Change in Family Cohesion
Tijdsspanne: Baseline, 6 months, 12 months
|
The cohesion subscale (10 items) of the Family Adaptability and Cohesion Evaluation Scale III measures the emotional bonding family members have with one another.
Items like "Family members ask each other for help" rated on a 5-point Likert scale from "almost never" to "almost always."
|
Baseline, 6 months, 12 months
|
|
Change in Family Emotional Involvement
Tijdsspanne: Baseline, 6 months, 12 months
|
The family emotional involvement (7 items) of the Family Emotional Involvement and Criticism Scale rate items on a 5-point Likert scale, as above.
|
Baseline, 6 months, 12 months
|
|
Change in Family Perceived Criticism
Tijdsspanne: Baseline, 6 months, 12 months
|
The perceived criticism (7 items) subscales of the Family Emotional Involvement and Criticism Scale rate items like on a 5-point Likert scale, as above.
|
Baseline, 6 months, 12 months
|
|
Change in Family Collaborative problem solving
Tijdsspanne: Baseline, 6 months, 12 months
|
The Family Problem-Solving Communication Index (10 items) was used to measure the specific communication style that families use to manage and solve problems and conflicts in various types of stressful situations.
Consisting of 2 subscales, affirmatory communication and incendiary communication, the response options were "false," "mostly false," "mostly true," and "true."
|
Baseline, 6 months, 12 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Candice L Alick, PhD, Morehouse School of Medicine
- Hoofdonderzoeker: Tennille Leak-Johnson, PhD, Morehouse School of Medicine
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1R01MD021606 (Subsidie/contract van de Amerikaanse NIH)
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