ObesityRESETNCT04335799
Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools
A study testing Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training and Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics in people with Obesity, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training and Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of at least 30 kg/m^2
- elevated stress levels based on perceived stress scale score
- self-identified as black race
Who cannot join
- pregnant or are planning to become pregnant in the next year
- known major medical or psychological condition known to influence body weight loss (e.g., medicated or poorly controlled diabetes (fasting blood glucose > 126 mg/dL), cardiovascular event in the preceding 12 months, history of gastric bypass surgery, bariatric surgery, or eating disorder)
- history of psychiatric hospitalization in past 2 years
- history of substance abuse or eating disorder
- any condition for which a medical professional has suggested diet modification, physical activity, and/or weight reduction would be contraindicated.
- currently taking medications for weight loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Weight Loss Outcomes of Black Women Using a Culturally-Relevant Stress-Management Enhanced Behavioral Weight Loss Intervention
The purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. Participants will be randomized to receive either a behavioral weight loss intervention with a focus on stress management or the weight loss intervention alone for 26 sessions.
- Conditions
- Obesity
- Being tested
- Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training, Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management trainingBehavioural
12-month evidence based weight loss intervention with additional training on stress management strategies
Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topicsBehavioural
12-month evidence based weight loss intervention with an attention control of general women's health topics
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Plus Stress Management | Experimental | Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training Receives: Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training |
| Weight Loss Only | Active comparator | Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics Receives: Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-month mean weight change of participants using SECA scale
weight change as measured by a SECA scale in kilograms and baseline and month 4 will be calculated and averaged
Measured: Baseline to Month 4
12-month mean weight change of participants using SECA scale
weight change as measure by a SECA scale in kilograms and baseline and month 12 will be calculated and averaged
Measured: Baseline to Month 12
Secondary outcomes (2)
mean change in perceived stress using Perceived Stress Scale-10 score
Perceived stress as measured with a validated survey will be assessed at baseline and month to assess changes in participant's stress
Measured: Baseline to Month 4
mean change in perceived stress using Perceived Stress Scale-10 score
Perceived stress as measured with a validated survey will be assessed at baseline and month 12 to assess changes in participant's stress
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start12 Oct 2021
- Primary completion19 Dec 2025
- Study completion31 Mar 2027 (estimated)
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 ObesityStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany L Carson, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335799
- Sponsor's protocol ID
- MCC-21236
- Other IDs
- R01DK125367
- Acronym
- RESET
- Status last verified
- Jul 2026
- First submitted
- 30 Jan 2020
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buro AW, Baskin M, Miller D, Ward T, West DS, Gore LR, Gwede CK, Epel E, Carson TL. Rationale and study protocol for a randomized controlled trial to determine the effectiveness of a culturally relevant, stress management enhanced behavioral weight loss intervention on weight loss outcomes of black women. BMC Public Health. 2022 Jan 28;22(1):193. doi: 10.1186/s12889-022-12519-z.
PubMed 35090433
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Weight Loss Outcomes of Black Women Using a Culturally-Relevant Stress-Management Enhanced Behavioral Weight Loss Intervention
- ClinicalTrials.gov ID
- NCT04335799
- Acronym / sponsor ID
- RESET / MCC-21236
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 341 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Apr 2020 (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.
The purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. Participants will be randomized to receive either a behavioral weight loss intervention with a focus on stress management or the weight loss intervention alone for 26 sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Plus Stress Management | Experimental | Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management trainingDiabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training |
| Weight Loss Only | Active comparator | Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topicsDiabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI of at least 30 kg/m^2
- elevated stress levels based on perceived stress scale score
- self-identified as black race
Key exclusion criteria (6 listed)
- pregnant or are planning to become pregnant in the next year
- known major medical or psychological condition known to influence body weight loss (e.g., medicated or poorly controlled diabetes (fasting blood glucose > 126 mg/dL), cardiovascular event in the preceding 12 months, history of gastric bypass surgery, bariatric surgery, or eating disorder)
- history of psychiatric hospitalization in past 2 years
- history of substance abuse or eating disorder
- any condition for which a medical professional has suggested diet modification, physical activity, and/or weight reduction would be contraindicated.
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 |
|---|---|---|
| Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training12-month evidence based weight loss intervention with additional training on stress management strategies | Behavioural | Weight Loss Plus Stress Management |
| Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics12-month evidence based weight loss intervention with an attention control of general women's health topics | Behavioural | Weight Loss Only |
Primary outcome
4-month mean weight change of participants using SECA scale
Time frame: Baseline to Month 4
weight change as measured by a SECA scale in kilograms and baseline and month 4 will be calculated and averaged
12-month mean weight change of participants using SECA scale
Time frame: Baseline to Month 12
weight change as measure by a SECA scale in kilograms and baseline and month 12 will be calculated and averaged
2 secondary outcomes
mean change in perceived stress using Perceived Stress Scale-10 score
Time frame: Baseline to Month 4
mean change in perceived stress using Perceived Stress Scale-10 score
Time frame: Baseline to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Derived from this study: PubMed 35090433Buro AW, Baskin M, Miller D, Ward T, West DS, Gore LR, Gwede CK, Epel E, Carson TL. Rationale and study protocol for a randomized controlled trial to determine the effectiveness of a culturally relevant, stress management enhanced behavioral weight loss intervention on weight loss outcomes of black women. BMC Public Health. 2022 Jan 28;22(1):193. doi: 10.1186/s12889-022-12519-z.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tiffany L Carson, PhD principal investigator
Moffitt 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 Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training and Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics in people with Obesity, run by H. Lee Moffitt Cancer Center and Research Institute 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
4-month mean weight change of participants using SECA scale (time frame: Baseline to Month 4). The study lists 2 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 NCT04335799, 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 30 Jul 2026.