NCT04335799

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
341

participants targeted

Target at P75+ for not_applicable obesity

Timeline
11mo left

Started Oct 2021

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Oct 2021Mar 2027

First Submitted

Initial submission to the registry

January 30, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 12, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2026

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

4.5 years

First QC Date

January 30, 2020

Last Update Submit

May 14, 2026

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Baseline to Month 12

Secondary Outcomes (2)

  • mean change in perceived stress using Perceived Stress Scale-10 score

    Baseline to Month 4

  • mean change in perceived stress using Perceived Stress Scale-10 score

    Baseline to Month 12

Study Arms (2)

Weight Loss Plus Stress Management

EXPERIMENTAL

Diabetes Prevention Program Intensive Lifestyle Intervention augmented with stress management training

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

Behavioral: Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topics

Interventions

Diabetes Prevention Program Intensive Lifestyle Intervention plus general women's health topicsBEHAVIORAL

12-month evidence based weight loss intervention with an attention control of general women's health topics

Weight Loss Only
Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management trainingBEHAVIORAL

12-month evidence based weight loss intervention with additional training on stress management strategies

Weight Loss Plus Stress Management

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of at least 30 kg/m\^2
  • elevated stress levels based on perceived stress scale score
  • self-identified as black race

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • 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.

    PMID: 35090433DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tiffany L Carson, PhD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

April 6, 2020

Study Start

October 12, 2021

Primary Completion

April 14, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)