WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)

NCT06172582 | Completed

• 2 other identifiers: HM20024014 Phase 21R01DK132373
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The treatment program being tested in this research study aims to address these factors and increase outcomes for the study population. The purpose of this research study is to find out about the feasibility and acceptability of using house chats (HC) as a model for a weight loss program in a real-world, community-based setting.

Conditions

Obesity

Keywords

Cardiometabolic Disease

Outcome Measures

Primary Outcomes (5)

• Participants in the intervention ward will manifest clinically significant change in physical activity outcomes targeted in the intervention.

  Physical activity will be objectively assessed via accelerometers. Total minutes of physical activity is the main outcome, but will also examine minutes of light and moderate-to-vigorous physical activity. The threshold for clinically meaningful is 150 minutes / week which is consistent with a wealth of evidence and current evidence-based guidelines.

  12 week and 24 weeks post-treatment

• Participants in the intervention ward will manifest clinically significant Change in diet behavioral outcomes targeted in the intervention.

  The EARLY Trials 4-item Sugar Sweetened Beverage Questionnaire and 10-item NCI fruit and vegetable screener (all day version) to assess changes in core intervention targets will be administered. While any changes in these outcomes would be meaningful if sustained over time, the results will compare to current guidelines / recommendations. Specifically, changing sugar intake no more than 9 teaspoons/36 grams/150 calories for men and 6 teaspoons/25 grams/100 calories for women per and increasing fruit and vegetable intake to at least 5 total servings per day are consistent with current guidelines.

  12 week and 24 weeks post-treatment

• Intervention ward participants will manifest clinically significant change in adiposity

  The thresholds for clinically meaningful will be different based on baseline weight status. For those without overweight or obesity staying within 1lb of baseline weight would be considered clinically meaningful. For absolute change in body mass index and percent change of initial body weight we will report the results stratified by weight status (BMI \> 25 or BMI \< 25) since weight management targets would be distinct for those with overweight / obesity vs. those classified as healthy weight (weight loss vs. weight gain prevention, respectively).\] Weight will be measured with the Tanita BWB 800 digital portable scale . BMI will be calculated using the obtained weight and height measurements. Weight will be measured with the scale noted above and height will be measure via the Seca 213 portable stadiometer. Then, we will calculate BMI using the body mass index (kg/m2) = (average weight in kg) / (average height in m)2.

  12 week and 24 weeks post-treatment

• Subjects will manifest clinically significant change in Secondary markers of cardiometabolic risk through changed blood pressure readings

  Clinically significant changes in blood pressure include a systolic blood pressure (SBP) changing ≥ 10mmHg or a diastolic blood pressure (DBP) changing ≥ 5mmHg as this can change the category that a participant's blood pressure is categorized as. Please see the table below from AHA for reference. We will measure blood pressure using the GE Carescape V100 Monitor and Gulick II Tape Measure.

  12 week and 24 weeks post-treatment

• Subjects will manifest clinically significant change in secondary markers of cardiometabolic risk with changed Fasting Glucose Values

  Fasting glucose values are categorized as within normal range (≤ 99 mg/dL), in prediabetes stage (100-125 mg/dL), or having diabetes (≥ 126 mg/dL). A change for those that are in the prediabetes or diabetes categories will include their follow up values decreasing, while for those that are found to be in the normal range at baseline we will want them to maintain. Fasting glucose will be measured using the ACCU-CHEK Inform II Meter and ACCU-CHEK Inform II Test Strips.

  12 week and 24 weeks post-treatment

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will be randomized to intervention and will receive the 12-week program.

Behavioral: 12-week lifestyle intervention

Delayed Intervention Control

ACTIVE COMPARATOR

Participants will be randomized to delayed intervention control and will receive the same 12-week program.

Behavioral: 12-week lifestyle intervention

Interventions

12-week lifestyle intervention BEHAVIORAL

A 12-week lifestyle intervention delivered via weekly group meetings in the House Chat Leaders (HCL's) homes

Delayed Intervention Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or older
• Resident of Petersburg, VA

You may not qualify if:

• Dx of type 1 diabetes mellitus
• Current treatment for cancer
• Medical conditions that may increase risk for participating in unsupervised
• Hospitalization for depression or other psychiatric disorder within the past 12 months
• Uncontrolled psychotic disorder or bipolar disorder
• Currently pregnant or lactating or planning to become pregnant within the study period
• Current involvement in a weight loss program or current use of weight loss medication
• Inability to speak and read English
• Planning to move from the Petersburg area within the study period

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Moghboeba Mosavel

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This behavioral weight loss intervention will span 12 weeks. Participants will be randomized to one of two groups within ward (intervention and delayed intervention control) wherein all participants will receive the same 12-week program.

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: December 15, 2023
• Study Start: November 28, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (1)