An interventional study of Family Skills Training Session Quantity: 5 and Family Skills Training Session Mode: In-person in Obesity and Overweight, Diabetes Mellitus and Weight Loss, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn the best combination of family components that yields optimal weight loss among Black adults. The main question it aims to answer is:
What combination of four family components in combination with a standard behavioral weight loss program yields optimal weight loss among Black adults? Researchers will compare different combinations of family skills components (communication content, cohesion content, number of sessions, and mode of delivery) to see the best weight loss.
Participants will:
This clinical trial aims to determine the most effective combination of family components to achieve optimal weight loss among Black adults. The main focus is to assess how different combinations of four family skills components-communication content, cohesion content, number of sessions, and mode of delivery-work together with a standard behavioral weight loss program.
Participants will engage in a 6-month behavioral weight loss intervention, which includes attending group weight loss sessions and family-based dyad sessions. They will also track their weight, dietary intake, and physical activity.
This is a 2 x4 factorial design with 16 study conditions.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 256 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 29, 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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion
Behavioral: Family Skills Training Session Quantity: 5 · Behavioral: Family Skills Training Session Mode: In-person · Behavioral: Family Skills Training Content: Communication · Behavioral: Family Skills Training Content: Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion
Behavioral: Family Skills Training Session Quantity: 5 · Behavioral: Family Skills Training Session Mode: In-person · Behavioral: Family Skills Training Content: Communication · Behavioral: Family Skills Training Content: No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication
Behavioral: Family Skills Training Session Quantity: 5 · Behavioral: Family Skills Training Session Mode: In-person · Behavioral: Family Skills Training Content: Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering no communication but no cohesion
Behavioral: Family Skills Training Session Quantity: 5 · Behavioral: Family Skills Training Session Mode: In-person · Behavioral: Family Skills Training Content: Communication · Behavioral: Family Skills Training Content: Cohesion · Behavioral: Family Skills Training Content: No Communication
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion
Behavioral: Family Skills Training Session Quantity: 5 · Behavioral: Family Skills Training Content: Communication · Behavioral: Family Skills Training Content: Cohesion · Behavioral: Family Skills Training Session Mode: Online
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion
Behavioral: Family Skills Training Session Quantity: 5 · Behavioral: Family Skills Training Content: Communication · Behavioral: Family Skills Training Session Mode: Online · Behavioral: Family Skills Training Content: No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication
Behavioral: Family Skills Training Session Quantity: 5 · Behavioral: Family Skills Training Content: Cohesion · Behavioral: Family Skills Training Session Mode: Online · Behavioral: Family Skills Training Content: No Communication
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering no communication and no cohesion
Behavioral: Family Skills Training Session Quantity: 5 · Behavioral: Family Skills Training Session Mode: Online · Behavioral: Family Skills Training Content: No Communication · Behavioral: Family Skills Training Content: No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion
Behavioral: Family Skills Training Session Mode: In-person · Behavioral: Family Skills Training Content: Communication · Behavioral: Family Skills Training Content: Cohesion · Behavioral: Family Skills Training Session Quantity: 10
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion
Behavioral: Family Skills Training Session Mode: In-person · Behavioral: Family Skills Training Content: Communication · Behavioral: Family Skills Training Session Quantity: 10 · Behavioral: Family Skills Training Content: No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering cohesion but no no communication
Behavioral: Family Skills Training Session Mode: In-person · Behavioral: Family Skills Training Content: Cohesion · Behavioral: Family Skills Training Session Quantity: 10 · Behavioral: Family Skills Training Content: No Communication
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering no communication and no cohesion
Behavioral: Family Skills Training Session Mode: In-person · Behavioral: Family Skills Training Session Quantity: 10 · Behavioral: Family Skills Training Content: No Communication · Behavioral: Family Skills Training Content: No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion
Behavioral: Family Skills Training Content: Communication · Behavioral: Family Skills Training Content: Cohesion · Behavioral: Family Skills Training Session Quantity: 10 · Behavioral: Family Skills Training Session Mode: Online
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion
Behavioral: Family Skills Training Content: Communication · Behavioral: Family Skills Training Session Quantity: 10 · Behavioral: Family Skills Training Session Mode: Online · Behavioral: Family Skills Training Content: No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication
Behavioral: Family Skills Training Content: Cohesion · Behavioral: Family Skills Training Session Quantity: 10 · Behavioral: Family Skills Training Session Mode: Online · Behavioral: Family Skills Training Content: No Communication
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering no communication and no cohesion
Behavioral: Family Skills Training Session Quantity: 10 · Behavioral: Family Skills Training Session Mode: Online · Behavioral: Family Skills Training Content: No Communication · Behavioral: Family Skills Training Content: No Cohesion
The number of family skills training sessions administered: 5 sessions
The mode of administration of family skills training sessions: in person or online
The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution
The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion
The number of family skills training sessions administered: 10 sessions
The mode of administration of family skills training sessions: online
The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution
The content of family skills training sessions administered focused on cohesion: no cohesion
Change in Body weight
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
Time frame: baseline and 6 months
Mean Change in Blood Pressure
Both systolic and diastolic blood Pressure measured after 5 minutes of rest and taken in the same position throughout the study.
Time frame: baseline and 6 months
Change in skin carotenoids
To assess fruit and vegetable intake, skin carotenoids will be measured using a reflection spectroscopy device ("Veggie Meter") The Veggie Meter uses reflection spectroscopy and a light-emitting diode (LED) light to measure the skin's carotenoids on a scale of 0 to 800. Higher scores indicate more carotenoids, which usually means the person has eaten more fruits and vegetables.
Time frame: baseline and 6 months
Change in physical activity steps
To assess physical activity, the number of daily steps will be captured using a Fitbit wearable fitness tracker
Time frame: baseline and 6 months
Change in glycosylated hemoglobin (A1c)
Changes in A1c will be measured using a, Point of Contact A1c -Siemens Diabetes 5075 A1C Analyzer
Time frame: baseline and 6 months
Current Subjective Social Status
Assesses a person's perceived rank relative to others in their group. The MacArthur Scale of Subjective Social Status (MacArthur SSS Scale) is a single-item measure that assesses a person's perceived rank relative to others in their group. Respondents view a drawing of a ladder with 10 rungs, and either read or hear that the ladder represents where people stand in society. Respondents further read or hear: "At the top of the ladder are the people who are the best off, those who have the most money, most education, and best jobs. At the bottom are the people who are the worst off, those who have the least money, least education, worst jobs, or no job. To score this measure, researchers simply note the number of the rung (1-10) on which the respondent placed their "X."
Time frame: baseline
Change in Quality of Life
12-Item Short Form Survey (SF-12) assessing the impact of health on an individual's everyday life. The 12-Item Short Form Survey (SF-12) is scored by calculating two main scores: a Physical Component Summary (PCS) and a Mental Component Summary (MCS), both ranging from 0 to 100, with higher scores indicating better physical and mental health respectively
Time frame: baseline and 6 months
Change in Depression
Patient Health Questionnaire -8 (PHQ-8). To score the Patient Health Questionnaire-8 (PHQ-8), add up the scores from each of the eight items, with each item rated on a scale from 0 ("not at all") to 3 ("nearly every day") - resulting in a total score ranging from 0 to 24; higher scores indicate greater depression severity; generally, a score of 10 or higher is considered clinically significant for major depression, while scores between 5-9 are considered mild depression and 10-14 moderate depression.
Time frame: baseline and 6 months
Change in Perceived stress
Measured using Perceived Stress Scale 4 (PSS-4). On the Perceived Stress Scale 4 (PSS-4), each question is scored on a 0-4 scale, with higher scores indicating greater perceived stress, and the total score is calculated by adding up all four items; the possible score range for the PSS-4 is therefore 0-16, with higher scores signifying higher levels of stress.
Time frame: baseline and 6 months
Change for 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 and 6 months
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 and 6 months
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 and 6 months
Changes in self-regulation
Treatment Self-Regulation Questionnaire. To score the Treatment Self-Regulation Questionnaire (TSRQ), each item is typically rated on a 7-point Likert scale, where 1 represents "Not at all true" and 7 represents "Very true," with higher scores indicating a greater degree of autonomous motivation for engaging in the targeted health behavior;
Time frame: baseline and 6 months
Changes in nutrition self-efficacy
Nutrition Self-efficacy scale (5 items). To score a 5-item Nutrition Self-Efficacy scale, typically each item is rated on a Likert scale (usually 1-5, with 1 being "not at all confident" and 5 being "very confident"), and then the scores from all five items are added together to produce a total score, with higher scores indicating greater perceived self-efficacy in managing nutrition choices; the total score range would be between 5 (lowest self-efficacy) and 25 (highest self-efficacy)
Time frame: baseline and 6 months
Physical Activity Readiness
PHYSICAL ACTIVITY READINESS QUESTIONNAIRE (PAR-Q) \& You. The Physical Activity Readiness Questionnaire (PAR-Q) is a seven-question screening tool that helps determine if a person is healthy enough to exercise. If you answer "yes" to one or more questions, you should consult a physician before starting an exercise program
Time frame: baseline
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 and 6 months
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 and 6 months
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 and 6 months
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 and 6 months
Personal Network Survey
Social Network Analysis using Network Canvas software
Time frame: baseline
Change for 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 and 6 months
Plan to share: Yes — We plan to preserve all the study data and to make it available to other researchers as appropriate, except that audio recordings of semi-structured interviews will NOT be made available, but the transcripts of these interviews will be made available. We do not plan to transcribe the fidelity audio recordings, so these data will not be made available. Our rationale for not sharing the audio recorded data is to minimize the risk of loss of confidentiality. All stored data are de-identified. Data will be made available no later than the time of an associated publication.
Time frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
Access criteria: When data sharing is permitted, a Data Use Agreement (DUA) specifying the uses of such data to be shared must be in place before any data is shared. Requests can be submitted to the Industry Contracting for processing. The Principal Investigator must confirm that the DUA has been fully executed and IRB, IEC, or REB approval has been granted before sharing data.
No publications or documents are linked to this record.
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 ↗
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