Obesity & OverweightTHRIVE NOWNCT07897890
Testing Health-Related Interventions: Voices of Equity Needed to Overcome Weight-bias in Obesity-Cancer Care
A study testing THRIVE NOW in people with Obesity & Overweight and Breast Cancer, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Obesity & Overweight, Breast Cancer
- What is being tested?
- THRIVE NOW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2024to 8 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 to 65 years of age
- 30 ≤ BMI kg/m2 < 45
- Identifies as Black or African American race
- Patient has been diagnosed with stage I-IIIA breast cancer without evidence of distant disease at time of study entry.
- Patient has completed surgery, radiation therapy, chemotherapy, and/or biologic therapy ≥2 weeks but ≤6 years prior (ongoing endocrine therapy is allowed).
- Patient is willing to complete an 8-week in-person behavioral weight loss program
Who cannot join
- Patient has a previous cancer diagnosis besides breast (non-melanoma skin cancer or melanoma in situ is allowed).
- Patient is currently participating in ACT, CBT, formal mindfulness meditation training, or any other research study that has the potential to skew results of this study or the study in which the person is participating.
- History of bariatric surgery or planning to get bariatric surgery over next 3 months
- Pregnant or planning to become pregnant over next 3 months
- Currently breastfeeding
- History of or current serious eating disorder pathology
Show all 14Show fewer
- Current severe depression (≥ 5 on PHQ-2)
- History of or current substance use disorder
- History of hypomanic or manic episode
- History of psychotic episode
- History of neurological disorder or head injury (e.g., stroke, epilepsy, loss of consciousness >10 min)
- Recent significant weight loss (>5% of total body weight)
- Current Type I Diabetes
- Disease that impacts weight (e.g., Cushing's syndrome, hypothyroidism).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- Within 6 weeks before the first weight loss session, participants will be asked to complete a study survey assessing cancer-related symptoms (fatigue, pain) and psychobehavioral factors. The survey should take 45 minutes to complete.
- In the 2 weeks prior to the first weight loss session, participants will be asked to come to the study office for measurement of height and weight, as well as waist and hip circumference and to complete a short survey.
- Participants will also have their weight measured on a medical-grade scale every 2 weeks during the intervention. Although other participants will attend the group sessions, individual weight measurements will be conducted privately and will not be shared with the group.
- Participants will be encouraged to modify their eating habits by increasing vegetable and fruit consumption and decreasing consumption of high-calorie, low-nutrient foods (e.g., candy). However, they will be asked to eat at least 1200 calories/day.
- Participants will be encouraged to safely increase activity levels through activities appropriate to their preferences and abilities, such as walking or fitness classes.
- Participants will be asked to track food intake and physical activity in a diary.
- Participants may choose to have their fruit and vegetable intake assessed using the Veggie Meter, a noninvasive device that scans a finger using light to estimate levels of skin pigments associated with fruit and vegetable consumption.
- Participants will learn and practice psychological strategies designed to support healthy behavior change.
- At the 8th and final weight loss session, participants will have their weight and waist and hip circumference measured using standardized procedures.
- After the 8th and final session, participants will complete a study survey assessing cancer-related symptoms (fatigue, pain) and psychobehavioral factors. The survey is expected to take approximately 45 minutes to complete.
- Conditions
- Obesity & Overweight, Breast Cancer
- Being tested
- THRIVE NOW
- Keywords
- weight loss, breast cancer survivors, acceptance-based treatment, acceptance and commitment therapy
- Medical subject headings
- Obesity, Overweight, Breast Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE NOWBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE NOW | Experimental | 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.) Receives: Behavioral: THRIVE NOW |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: End of treatment at 8 weeks after baseline
Secondary outcomes (8)
Fat mass
Change in fat mass (kg) from baseline to post-treatment measured using the InBody 270 Bio-electrical Impedance Device
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From baseline to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start6 Jun 2024
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- IU Simon Comprehensive Cancer Center
- Responsible party
- Principal investigator, Misty Hawkins, Indiana University
- Investigators
- Misty Hawkins, PhD, Principal investigator, Indiana UniversityShelley Johns, PsyD, Principal investigator, Indiana University Melvin and Bren Simon Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897890
- Sponsor's protocol ID
- 21767
- Acronym
- THRIVE NOW
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the small nature of this pilot study (N = 12) sharing individual participant data might be identifiable.
Publications
Sinclair K, Hawkins MAW, Murray M, McChristian J, Werner NE, Ramly E, Zoh R, Allen-Watts K, Ballinger T, Johns SA. Use of Co-Design Approaches to Identify Barriers to Health-Promoting Behaviors among African American Breast Cancer Survivors with Comorbid Obesity. Health Behav Res. 2024 Oct;7(4):10.4148/2572-1836.1256. doi: 10.4148/2572-1836.1256.
PubMed 40843140
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Health-Related Interventions: Voices of Equity Needed to Overcome Weight-bias in Obesity-Cancer Care
- ClinicalTrials.gov ID
- NCT07897890
- Acronym / sponsor ID
- THRIVE NOW / 21767
- Conditions
- Obesity & Overweight, Breast Cancer
- Keywords
- weight loss, breast cancer survivors, acceptance-based treatment, acceptance and commitment therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- IU Simon Comprehensive Cancer Center
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Within 6 weeks before the first weight loss session, participants will be asked to complete a study survey assessing cancer-related symptoms (fatigue, pain) and psychobehavioral factors. The survey should take 45 minutes to complete.
- In the 2 weeks prior to the first weight loss session, participants will be asked to come to the study office for measurement of height and weight, as well as waist and hip circumference and to complete a short survey.
- Participants will also have their weight measured on a medical-grade scale every 2 weeks during the intervention. Although other participants will attend the group sessions, individual weight measurements will be conducted privately and will not be shared with the group.
- Participants will be encouraged to modify their eating habits by increasing vegetable and fruit consumption and decreasing consumption of high-calorie, low-nutrient foods (e.g., candy). However, they will be asked to eat at least 1200 calories/day.
- Participants will be encouraged to safely increase activity levels through activities appropriate to their preferences and abilities, such as walking or fitness classes.
- Participants will be asked to track food intake and physical activity in a diary.
- Participants may choose to have their fruit and vegetable intake assessed using the Veggie Meter, a noninvasive device that scans a finger using light to estimate levels of skin pigments associated with fruit and vegetable consumption.
- Participants will learn and practice psychological strategies designed to support healthy behavior change.
- At the 8th and final weight loss session, participants will have their weight and waist and hip circumference measured using standardized procedures.
- After the 8th and final session, participants will complete a study survey assessing cancer-related symptoms (fatigue, pain) and psychobehavioral factors. The survey is expected to take approximately 45 minutes to complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pilot study
| Arm | Type | Receives |
|---|---|---|
| THRIVE NOW | Experimental | Behavioral: THRIVE NOWAcross 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.) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 21 to 65 years of age
- 30 ≤ BMI kg/m2 < 45
- Identifies as Black or African American race
- Patient has been diagnosed with stage I-IIIA breast cancer without evidence of distant disease at time of study entry.
- Patient has completed surgery, radiation therapy, chemotherapy, and/or biologic therapy ≥2 weeks but ≤6 years prior (ongoing endocrine therapy is allowed).
Key exclusion criteria (14 listed)
- Patient has a previous cancer diagnosis besides breast (non-melanoma skin cancer or melanoma in situ is allowed).
- Patient is currently participating in ACT, CBT, formal mindfulness meditation training, or any other research study that has the potential to skew results of this study or the study in which the person is participating.
- History of bariatric surgery or planning to get bariatric surgery over next 3 months
- Pregnant or planning to become pregnant over next 3 months
- Currently breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THRIVE NOWBreast 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. | Behavioural | THRIVE NOW |
Primary outcome
Number of participants enrolled and retained
Time frame: End of treatment at 8 weeks after baseline
The percentage of breast cancer survivors who enrolled in the study and were retained at post-treatment (0-100%; higher percentage = more retained)
Attendance rates (Acceptability)
Time frame: Weekly attendance at each of the 8 THRIVE NOW sessions from baseline to last session
Percentage of sessions that participants attended in person and/or made-up (0-100%; higher percentage = higher attendance)
Acceptability (Program Evaluation)
Time frame: End of treatment at 8 weeks after baseline
Scores on the Treatment Acceptability/Adherence Scale (TAAS) (10-70; higher scores = greater acceptability/adherence ratings)
8 secondary outcomes
Fat mass
Time frame: From baseline to the end of treatment at 8 weeks
Cancer-related symptom (fatigue severity)
Time frame: From baseline to the end of treatment at 8 weeks
Cancer-related symptom (fatigue interference)
Time frame: From baseline to the end of treatment at 8 weeks
Cancer-related symptoms (pain severity)
Time frame: From baseline to the end of treatment at 8 weeks
Cancer-related symptoms (pain interference)
Time frame: From baseline to the end of treatment at 8 weeks
Processed Food Consumption
Time frame: From baseline to the end of treatment at 8 weeks
Physical Activity
Time frame: From baseline to the end of treatment at 8 weeks
Psychological Inflexibility
Time frame: From baseline to the end of treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 40843140Sinclair K, Hawkins MAW, Murray M, McChristian J, Werner NE, Ramly E, Zoh R, Allen-Watts K, Ballinger T, Johns SA. Use of Co-Design Approaches to Identify Barriers to Health-Promoting Behaviors among African American Breast Cancer Survivors with Comorbid Obesity. Health Behav Res. 2024 Oct;7(4):10.4148/2572-1836.1256. doi: 10.4148/2572-1836.1256.
- Individual participant dataSharing planned: No. Given the small nature of this pilot study (N = 12) sharing individual participant data might be identifiable.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misty Hawkins, PhD principal investigator
Indiana University
Shelley Johns, PsyD principal investigator
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE NOW in people with Obesity & Overweight and Breast Cancer, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants enrolled and retained (time frame: End of treatment at 8 weeks after baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07897890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.