An interventional study of THRIVE NOW in Obesity & Overweight and Breast Cancer, sponsored by Indiana University. Completed at 1 site in United States. Open to female participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
This study is testing an 8-week behavioral weight loss and wellness program adapted to the needs of Black/African American breast cancer survivors. The study will also examine psychological and physical factors that may be associated with weight loss outcomes.
Participants will take part in the study for approximately 8 weeks and attend up to 8 weekly, 2-hour group sessions. During these sessions, participants will learn and practice strategies to support weight loss and will be asked to do the following:
6,583 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 12 is below the median of 77 across 5,091 interventional studies indexed under Obesity.
Browse Obesity studies →Indiana University is the lead sponsor of 983 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Across eight weekly 2-hour group sessions, Black or African American breast cancer survivors with obesity learn and practice behavioral weight-management skills, including healthy eating, physical activity, self-monitoring, and goal setting. Participants also learn adaptive coping skills, including acceptance of difficult thoughts, feelings, and bodily sensations; present-moment awareness through mindfulness practices; clarification of personal values; and setting goals consistent with those values. Through in-session and home practice, participants develop strategies for responding more adaptively to challenges such as distress and urges that may interfere with weight-management goals. Participants receive handouts on session topics and are asked to track multiple behaviors (e.g., food intake, physical activity, sleep, etc.)
Behavioral: THRIVE NOW
Breast cancer survivors participating in the THRIVE NOW arm learn and practice behavioral weight-management strategies and mindfulness- and acceptance-based coping skills to support healthy lifestyle changes and weight loss.
Number of participants enrolled and retained
The percentage of breast cancer survivors who enrolled in the study and were retained at post-treatment (0-100%; higher percentage = more retained)
Time frame: End of treatment at 8 weeks after baseline
Attendance rates (Acceptability)
Percentage of sessions that participants attended in person and/or made-up (0-100%; higher percentage = higher attendance)
Time frame: Weekly attendance at each of the 8 THRIVE NOW sessions from baseline to last session
Acceptability (Program Evaluation)
Scores on the Treatment Acceptability/Adherence Scale (TAAS) (10-70; higher scores = greater acceptability/adherence ratings)
Time frame: End of treatment at 8 weeks after baseline
Fat mass
Change in fat mass (kg) from baseline to post-treatment measured using the InBody 270 Bio-electrical Impedance Device
Time frame: From baseline to the end of treatment at 8 weeks
Cancer-related symptom (fatigue severity)
Fatigue severity using the Fatigue Symptom Inventory (FSI) (0-10; with higher scores = more severe fatigue)
Time frame: From baseline to the end of treatment at 8 weeks
Cancer-related symptom (fatigue interference)
Fatigue interference using the Fatigue Symptom Inventory (FSI) (0-70; with higher scores = more fatigue interference)
Time frame: From baseline to the end of treatment at 8 weeks
Cancer-related symptoms (pain severity)
Pain severity assessed using the PROMIS Pain Intensity Short Form (T-score 50 +/- 10; higher scores = greater pain severity)
Time frame: From baseline to the end of treatment at 8 weeks
Cancer-related symptoms (pain interference)
Pain interference assessed using the PROMIS Pain Interference Short Form (T-score 50 +/- 10; higher scores = greater pain interference)
Time frame: From baseline to the end of treatment at 8 weeks
Processed Food Consumption
Processed food consumption measure using the Screening Questionnaire of Highly Processed Food Consumption (sQ-HPF; 0-14; greater scores = higher processed food consumption)
Time frame: From baseline to the end of treatment at 8 weeks
Physical Activity
MET-Minutes from the Self-reported International Physical Activity Questionnaire (IPAQ; MET/min; higher scores = more physical activity)
Time frame: From baseline to the end of treatment at 8 weeks
Psychological Inflexibility
Scores on the Multidimensional Psychological Flexibility Inventory (MPFI; 1-6; greater scores = more inflexibility)
Time frame: From baseline to the end of treatment at 8 weeks
Skeletal Muscle Mass
Changes in skeletal muscle mass (kg) from baseline to post-treatment measured using the InBody 270 Bio-electrical Impedance Device
Time frame: From baseline to the end of treatment at 8 weeks
Total Body Weight
Changes in total body weight (kg) from baseline to post-treatment measured using the InBody 270 Bio-electrical Impedance Device
Time frame: From baseline to the end of treatment at 8 weeks
Body Fat Percentage
Change in body fat percentage from baseline to post-treatment measured using the InBody 270 Bio-electrical Impedance Device
Time frame: Baseline to post-treatment (8 weeks after baseline)
Body Mass Index
Change in body mass index (BMI; kg/m2) from baseline to post-treatment measured using the InBody 270 Bio-electrical Impedance Device
Time frame: Baseline to post-treatment (8 weeks after baseline)
Depressive symptoms
Scores on the Patient Health Questionnaire-8 (0-24; greater scores = greater depressive symptoms)
Time frame: Baseline to post-treatment (8 weeks after baseline)
Anxiety symptoms
Scores on the Generalized Anxiety Disorder-7 (0-21; greater scores = greater anxiety symptoms)
Time frame: Baseline to post-treatment (8 weeks after baseline)
Well-being
Scores on the BBC Subjective Well-Being Scale (24-120; greater scores = greater well-being)
Time frame: Baseline to post-treatment (8 weeks after baseline)
Eating Disorder Symptoms
Total scores on the Eating Disorder Examination - Questionnaire (EDE-Q; 0-6; higher scores = greater eating disorder psychopathology)
Time frame: From baseline to the end of treatment at 8 weeks
Internalized Weight Stigma
Scores on the Modified Weight Bias Internalization Scale (WBIS-M; 1-7; higher scores = greater internalization of weight stigma)
Time frame: From baseline to the end of treatment at 8 weeks
Body Appreciation
Scores on the Body Appreciation Scale (13-65; greater scores = greater appreciation)
Time frame: From baseline to the end of treatment at 8 weeks
Body Connection
Scale of Body Connection (0-4; greater scores = greater body awareness or dissociation depending on subscale)
Time frame: From baseline to the end of treatment at 8 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Given the small nature of this pilot study (N = 12) sharing individual participant data might be identifiable.
Ran from Jun 2024 to primary completion in Aug 2024, 2 months.
Of 2,256 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's 2 months is below that.
Counting every sponsor, half of 2,355 studies reached it within 25 months; a quarter within 11 and three quarters within 48.
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 completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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