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Weight LossNCT05944549

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

A study testing Financial coaching using TrustPlus, Brighter Bites and Noom in people with Weight Loss, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Weight Loss
What is being tested?
Financial coaching using TrustPlus, Brighter Bites and Noom
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
12 May 2023to 15 Feb 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

About this study

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
Being tested
Financial coaching using TrustPlus, Brighter Bites, Noom
Keywords
weight loss, financial coaching, Cognitive functioning, metabolic functioning, psychosocial measures, health behaviors
Medical subject headings
Weight Loss, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Financial coaching using TrustPlusBehavioural

    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.

  • Brighter BitesBehavioural

    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.

  • NoomBehavioural

    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.

Study groups in NCT05944549
Study groupRoleWhat they receive
Enhanced Intervention groupExperimentalNot described
Receives: Behavioral: Financial coaching using TrustPlus; Behavioral: Brighter Bites; Behavioral: Noom
lifestyle-intervention groupActive comparatorNot described
Receives: Behavioral: Brighter Bites; Behavioral: Noom

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent weight loss

    Average of the 2 weights will be calculated

    Measured: From baseline to 3 months

  2. Percent weight loss

    Average of the 2 weights will be calculated

    Measured: From baseline to 6 months

Secondary outcomes (25)
  1. Change in cognitive functioning as assessed by the Flanker Inhibitory test for inhibitory control

    The Flanker is a measure of executive function, specifically inhibitory control and attention. Total score ranges from 0-10, and a higher score indicates higher levels of ability to attend to relevant stimuli and inhibit attention from irrelevant stimuli.

    Measured: Baseline, 3 months, 6 months

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

    This test assesses working memory. Total score ranges from 0-26, with a higher score indicating better working memory.

    Measured: Baseline, 3 months, 6 months

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

    The DCCS is a measure of cognitive flexibility. Total score ranges from 0-10, and a higher score indicates a higher level of cognitive flexibility.

    Measured: Baseline, 3 months, 6 months

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

    This test measures speed of processing by asking participants to discern whether two side-by-side pictures are the same or not. Total score ranges from 0-130, with a higher score indicating greater processing speed.

    Measured: Baseline, 3 months, 6 months

  5. Change in lipid levels

    Measured: Baseline, 6 months

  6. Change in HbA1C

    Measured: Baseline, 6 months

  7. Change in fasting plasma glucose (FPG)

    Measured: Baseline, 6 months

  8. Change in diastolic blood pressure

    Measured: Baseline, 3 months, 6 months

  9. Change in systolic blood pressure

    Measured: Baseline, 3 months, 6 months

  10. Change in financial Stress as assessed by the Financial Stress Questionnaire

    Participants will be asked "Did any of the following happen to you because of a shortage of money in the past 6 months?," and participants will respond Yes or No to the following items. Data will be reported as the number of items for which participants answered "Yes"--total score ranges from 0-7, and a higher score indicates greater financial stress.

    Could not pay electricity, gas or telephone bills on time Could not pay the mortgage or rent on time Pawned or sold something Went without meals Was unable to heat home Asked for financial help from friends or family Asked for help from welfare/community organizations

    Measured: Baseline, 3 months, 6 months

  11. Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (affordability of household items)

    This section of the questionnaire evaluates the affordability of 7 spending sources in the household (home, clothing, furniture, car, food, medical care and leisure) on a 1 to 5 scale (strongly agree, agree, neutral, disagree, strongly disagree). Total score ranges from 7 to 35, with a higher score indicating less affordability of household items.

    Measured: Baseline, 3 months, 6 months

  12. Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (difficulty paying bills)

    This section of the questionnaire assesses how much difficulty participants had paying bills on a 1 to 5 scale (a great degree of difficulty to no difficulty at all), with a higher score indicating less difficulty paying bills.

    Measured: Baseline, 3 months, 6 months

  13. Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (money remaining at end of month)

    This section of the questionnaire assesses how much money was left at the end of the month on a 1 to 4 scale (not enough, just enough, some money left, more than enough money left over), with a higher score indicating more money left at the end of the month.

    Measured: Baseline, 3 months, 6 months

  14. Change in stress as assessed by the Perceived Stress Scale (PSS)

    This is a 10 item questionnaire and each is scored from 0(never) to 4(very often) for a maximum score range of 0-40 a higher number indicating more stress

    Measured: Baseline, 3 months, 6 months

  15. Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD7)

    This is a 7 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a maximum score range of 0-21 a higher number indicating more anxiety

    Measured: Baseline, 3 months, 6 months

  16. Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

    This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a maximum score range of 1-27 a higher number indicating more depression

    Measured: Baseline, 3 months, 6 months

  17. Change in quality of life as assessed by the Center for Disease Control (CDC)Population Well-Being Survey

    This is a 34-item questionnaire, and each item is scored on a 1-5 scale, with a higher value indicating greater well-being. Score on each of the 34 items will be reported in a separate row.

    Measured: Baseline, 3 months, 6 months

  18. Change in quality of life as assessed by the Short-Form 12 (SF-12)

    This is a 12 item questionnaire, scores range from 0 to 100, with higher scores indicating better physical and mental health functioning

    Measured: Baseline, 3 months, 6 months

  19. Change in quality of life as assessed by the Subjective Happiness Scale (SHS)

    This is a 4 item questionnaire and each is scored form 1-7, higher number indicating greater levels of happiness

    Measured: Baseline, 3 months, 6 months

  20. Change in quality of life as assessed by the Satisfaction with Life Scale (SWLS)

    This is a 5 item questionnaire and each is scored from 1( strongly disagree) to 7(strongly agree) for a maximum score range of 5-35, a higher number indicating better satisfaction

    Measured: Baseline, 3 months, 6 months

  21. Change in health behaviors as assessed by the NCI Automated 24-hour Dietary Assessment (ASA24) to analyze diet patterns

    This is a self reported outcome with support from a trained research dietitian by phone. ASA24 provides detailed information on intake of macronutrients and food groups, from which we can estimate the Healthy Eating Index,48 daily servings of fruit and vegetable intake, percent calorie intake from fat, protein and carbohydrates, and daily intake of sugar-sweetened beverages.

    Measured: Baseline, 3 months, 6 months

  22. Change in physical activity as assessed by the School Physical Activity and Nutrition (SPAN) survey

    Data will be reported in rows as the number of days per week that participants get the below amounts of exercise.

    Days per week of at least 60 min physical activity Days per week of at least 20 min vigorous physical activity Days per week of at least 30 min outdoor play

    Measured: Baseline, 3 months, 6 months

  23. Change in sedentary behavior as assessed by the School Physical Activity and Nutrition (SPAN) survey

    Data will be reported in rows as the number of hours per day that participants exhibit the below sedentary behaviors.

    Hours per day playing video games Hours per day watching Television or movies

    Measured: Baseline, 3 months, 6 months

  24. Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index(PSQI)

    This is a 19 item questionnaire. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.

    Measured: Baseline, 3 months, 6 months

  25. Change in food security as assessed by the National Health Interview Survey(NHIS) Food Insecurity Screener

    This is a 10 item questionnaire and the first 3 questions are scored from 1(often true) to 3(never true),the fifth and 10 questions are scored from 1(almost every month) to 3(only 1 or 2 months) and all other questions are answered as yes or no.

    Responses of "yes," "often," "sometimes," "almost every month," and "some months but not every month" were defined as affirmative responses. Based on the summed number of affirmative answers, food security was categorized into four levels: high food security (0 item affirmed), marginal food security (1-2 items affirmed), low food security (3-5 items affirmed), and very low food security (6-10 items affirmed). Participants with low or very low food security were considered food insecure.

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2023
  2. Study start12 May 2023
  3. Primary completion8 Feb 2025
  4. Study completion15 Feb 2025

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05944549
Sponsor's protocol ID
HSC-SPH-23-0002
Status last verified
Jul 2025
First submitted
5 Jul 2023
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Financial coaching using TrustPlus, Brighter Bites and Noom in people with Weight Loss, run by The University of Texas Health Science Center, Houston 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 5 inclusion and 4 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 9 Jul 2025. 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?

Percent weight loss (time frame: From baseline to 3 months). 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?
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 9 Jul 2025.

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