A Phase 2/3 interventional study of LEGACY DPP and DPP in Prediabetes and Weight Loss, sponsored by Morehouse School of Medicine. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Morehouse School of Medicine · Phase 2/3, Interventional, and Prevention
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:
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:
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.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 400 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Morehouse School of Medicine is the lead sponsor of 22 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 20, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the LEGACY DPP intervention
Behavioral: LEGACY DPP
Participants will receive the DPP intervention
Behavioral: DPP
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 * family health history sessions * core behavioral weight loss group sessions * a family skill building segment covering cohesion and communication during core sessions
The index partner will participate in standard DPP Participants will receive \- core behavioral weight loss group sessions
Mean Percent change in body weight
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
Time frame: Baseline, 6 months, 12 months
Mean Change in Blood Pressure ( Systolic and diastolic)
Blood Pressure ( Systolic and diastolic) measured after 5 minutes of rest and taken in the same position throughout the study.
Time frame: Baseline, 6 months, 12 months
Mean Change in glycosloated hemoglobin(HbA1c)(fasting, CLIA-waived assay)
Blood (\~20 mL) will be collected to assess changes in glycosloated hemoglobin
Time frame: Baseline, 6 months, 12 months
Mean Change in Fasting lipid panel (total cholesterol, High Denisity Lipids(HDL), Low density lipids (LDL), triglycerides)
Fasting lipid panel will measured to assess changes in total cholesterol, HDL, LDL, and triglycerides.
Time frame: Baseline, 6 months, 12 months
Mean Change in Skin carotenoids
Skin carotenoids will be assessed using a VeggieMeter as an indicator for fruit and vegetable intake.
Time frame: Baseline, 6 months, 12 months
Mean Change in Physical activity steps
Steps will be measured using an activity tracker e.g., Fitbit
Time frame: Baseline, 6 months, 12 months
Mean Change in Self-Regulation of Eating Behaviors
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
Time frame: Baseline, 6 months, 12 months
Mean Change in Self-Efficacy of Eating Behaviors
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.
Time frame: Baseline, 6 months, 12 months
Mean Change in Self-Efficacy of Physical Activity
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.
Time frame: Baseline, 6 months, 12 months
Mean Change in Social Support for Eating
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.
Time frame: Baseline, 6 months, 12 months
Mean Change in Social Support for Exercise
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.
Time frame: Baseline, 6 months, 12 months
Mean Change in Family Communication
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.
Time frame: Baseline, 6 months, 12 months
Mean Change in Family Cohesion
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."
Time frame: Baseline, 6 months, 12 months
Mean Change in Family Emotional Involvement
The family emotional involvement (7 items) of the Family Emotional Involvement and Criticism Scale rate items on a 5-point Likert scale, as above.
Time frame: Baseline, 6 months, 12 months
Mean Change in Family Perceived Criticism
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.
Time frame: Baseline, 6 months, 12 months
Mean Change in Family Collaborative problem solving
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."
Time frame: Baseline, 6 months, 12 months
No study locations are listed for this record.
Start is estimated for Jan 2027; primary completion for Jan 2031, 48 months later.
Start moved once since we started tracking on Sep 25, 2026: Nov 2026 → Jan 2027, on Oct 20, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Morehouse School of Medicine