Financial Coaching and Lifestyle Intervention for Diabetes Prevention in Low-income Families

NCT05944549 | Completed

• 1 other identifier: HSC-SPH-23-0002
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effect on weight and metabolic outcomes of an enhanced intervention, comprised of evidence-based financial coaching plus a lifestyle intervention vs. the lifestyle intervention alone

Conditions

Weight Loss

Keywords

weight loss; financial coaching; Cognitive functioning; metabolic functioning; psychosocial measures; health behaviors

Outcome Measures

Primary Outcomes (2)

• Percent weight loss

  Average of the 2 weights will be calculated

  From baseline to 3 months

• Percent weight loss

  Average of the 2 weights will be calculated

  From baseline to 6 months

Secondary Outcomes (25)

• Change in cognitive functioning as assessed by the Flanker Inhibitory test for inhibitory control

  Baseline, 3 months, 6 months

• Change in cognitive functioning as assessed by the List Sorting Working Memory Test for working memory

  Baseline, 3 months, 6 months

• Change in cognitive functioning as assessed by the Dimensional Change Card Sort Test (DCCS) for flexible shifting

  Baseline, 3 months, 6 months

• Change in cognitive functioning as assessed by the Pattern Comparison Processing Speed Test for processing speed

  Baseline, 3 months, 6 months

• Change in lipid levels

  Baseline, 6 months

Study Arms (2)

Enhanced Intervention group

EXPERIMENTAL

Behavioral: Financial coaching using TrustPlus; Behavioral: Brighter Bites; Behavioral: Noom

lifestyle-intervention group

ACTIVE COMPARATOR

Behavioral: Brighter Bites; Behavioral: Noom

Interventions

Financial coaching using TrustPlus BEHAVIORAL

Participants will be assigned a financial coach, who will, prepare a budget, conduct a soft pull of their credit report and score to analyze the credit score. Based on the participant's goals and financial limitations as highlighted by the, the participant and financial coach will create a personalized financial action plan comprising of strategies, follow-up actions, and resources, which includes unlimited access to one-on-one sessions with the financial coach. After the intensive financial coaching, participants will maintain access to the TrustPlus Portal and can continue to connect with their financial coach as needed throughout the 6-month intervention period. Participants will also have ongoing access to educational webinars and Trust+Ed, an interactive resource that provides self-guided content on many financial topics of interest, such as credit building and debt management.

Enhanced Intervention group

Brighter Bites BEHAVIORAL

Families receive a weekly distribution of fresh fruits and vegetables for 24 weeks, there will be Nutrition education in school throughout the school year using the evidence-based CATCH (Coordinated Approach to Child Health) program and weekly healthy recipe tastings and cooking skill demos for families during produce pick-up time.Fruit and vegetable access is complemented by CATCH, an evidence based, Texas Education Agency-approved, coordinated school health program designed to promote healthy nutrition, physical activity, and prevent obesity in schoolchildren. In addition, the Brighter Bites website and mobile app are freely available in English and Spanish.

Enhanced Intervention group; lifestyle-intervention group

Noom BEHAVIORAL

Participants will get access to Noom which is a mobile app for weight loss that shifts the paradigm from dieting to a digitally supported and artificial intelligence (AI)-driven cognitive behavioral therapy approach to support personalized behavior changes towards eating, physical activity and stress management. The Noom Healthy Weight curriculum covers foundations in weight loss, nutrition, physical activity, sleep and stress management.Daily tasks (e.g., weight and food logs, readings) are organized vertically in simple cards on the phone screen, allowing users to easily scroll through what needs to be done. It will pull physical activity data (e.g., steps) directly from the health app on smartphones or apps associated with external devices such as Fitbit. Furthermore, Noom stands out from other app-based programs by assigning a personal coach to each user, helping users navigate the emotional and physiological experiences of the Noom weight loss experience.

Enhanced Intervention group; lifestyle-intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking parents
• BMI\>25.0 at baseline
• must have a child participant in the Brighter Bites program at study enrollment
• own a smartphone (Android 6 and iPhone 12.4 or later)
• must able to participate in study activities

You may not qualify if:

• medications known to affect appetite or body composition (e.g., corticosteroids, antidepressants, beta blockers, sulfonylureas, insulin)
• currently diagnosed with conditions known to affect body composition or fat distribution (e.g., Cushing's syndrome, hypothyroidism)
• diagnosis of an eating disorder
• currently pregnant.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Bank of America Foundation: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Weight Loss; Health Behavior

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Shreela V Sharma, PhD,RD,LD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 13, 2023
• Study Start: May 12, 2023
• Primary Completion: February 8, 2025
• Study Completion: February 15, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)