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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Enhanced Intervention group | Experimental | Not described Receives: Behavioral: Financial coaching using TrustPlus; Behavioral: Brighter Bites; Behavioral: Noom |
| lifestyle-intervention group | Active comparator | Not described Receives: Behavioral: Brighter Bites; Behavioral: Noom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight loss
Average of the 2 weights will be calculated
Measured: From baseline to 3 months
Percent weight loss
Average of the 2 weights will be calculated
Measured: From baseline to 6 months
Secondary outcomes (25)
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
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
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
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
Change in lipid levels
Measured: Baseline, 6 months
Change in HbA1C
Measured: Baseline, 6 months
Change in fasting plasma glucose (FPG)
Measured: Baseline, 6 months
Change in diastolic blood pressure
Measured: Baseline, 3 months, 6 months
Change in systolic blood pressure
Measured: Baseline, 3 months, 6 months
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted13 Jul 2023
- Study start12 May 2023
- Primary completion8 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bank of America Foundation
- Responsible party
- Principal investigator, Shreela V Sharma, The University of Texas Health Science Center, Houston
- Investigators
- Shreela V Sharma, PhD,RD,LD, Principal investigator, The University of Texas Health Science Center, Houston
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Coaching and Lifestyle Intervention for Diabetes Prevention in Low-income Families
- ClinicalTrials.gov ID
- NCT05944549
- Acronym / sponsor ID
- HSC-SPH-23-0002
- Conditions
- Weight Loss
- Keywords
- weight loss, financial coaching, Cognitive functioning, metabolic functioning, psychosocial measures, health behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Bank of America Foundation
- Study start
- 12 May 2023 (actual)
- Primary completion
- 8 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 13 Jul 2023 (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 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Intervention group | Experimental | Behavioral: Financial coaching using TrustPlus, Behavioral: Brighter Bites, Behavioral: Noom |
| lifestyle-intervention group | Active comparator | Behavioral: Brighter Bites, Behavioral: Noom |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Financial coaching using TrustPlusParticipants 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. | Behavioural | Enhanced Intervention group |
| Brighter BitesFamilies 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. | Behavioural | Enhanced Intervention group, lifestyle-intervention group |
| NoomParticipants 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. | Behavioural | Enhanced Intervention group, lifestyle-intervention group |
Primary outcome
Percent weight loss
Time frame: From baseline to 3 months
Average of the 2 weights will be calculated
Percent weight loss
Time frame: From baseline to 6 months
Average of the 2 weights will be calculated
25 secondary outcomes
Change in cognitive functioning as assessed by the Flanker Inhibitory test for inhibitory control
Time frame: Baseline, 3 months, 6 months
Change in cognitive functioning as assessed by the List Sorting Working Memory Test for working memory
Time frame: Baseline, 3 months, 6 months
Change in cognitive functioning as assessed by the Dimensional Change Card Sort Test (DCCS) for flexible shifting
Time frame: Baseline, 3 months, 6 months
Change in cognitive functioning as assessed by the Pattern Comparison Processing Speed Test for processing speed
Time frame: Baseline, 3 months, 6 months
Change in lipid levels
Time frame: Baseline, 6 months
Change in HbA1C
Time frame: Baseline, 6 months
Change in fasting plasma glucose (FPG)
Time frame: Baseline, 6 months
Change in diastolic blood pressure
Time frame: Baseline, 3 months, 6 months
Change in systolic blood pressure
Time frame: Baseline, 3 months, 6 months
Change in financial Stress as assessed by the Financial Stress Questionnaire
Time frame: Baseline, 3 months, 6 months
Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (affordability of household items)
Time frame: Baseline, 3 months, 6 months
Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (difficulty paying bills)
Time frame: Baseline, 3 months, 6 months
Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (money remaining at end of month)
Time frame: Baseline, 3 months, 6 months
Change in stress as assessed by the Perceived Stress Scale (PSS)
Time frame: Baseline, 3 months, 6 months
Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD7)
Time frame: Baseline, 3 months, 6 months
Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 3 months, 6 months
Change in quality of life as assessed by the Center for Disease Control (CDC)Population Well-Being Survey
Time frame: Baseline, 3 months, 6 months
Change in quality of life as assessed by the Short-Form 12 (SF-12)
Time frame: Baseline, 3 months, 6 months
Change in quality of life as assessed by the Subjective Happiness Scale (SHS)
Time frame: Baseline, 3 months, 6 months
Change in quality of life as assessed by the Satisfaction with Life Scale (SWLS)
Time frame: Baseline, 3 months, 6 months
Change in health behaviors as assessed by the NCI Automated 24-hour Dietary Assessment (ASA24) to analyze diet patterns
Time frame: Baseline, 3 months, 6 months
Change in physical activity as assessed by the School Physical Activity and Nutrition (SPAN) survey
Time frame: Baseline, 3 months, 6 months
Change in sedentary behavior as assessed by the School Physical Activity and Nutrition (SPAN) survey
Time frame: Baseline, 3 months, 6 months
Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index(PSQI)
Time frame: Baseline, 3 months, 6 months
Change in food security as assessed by the National Health Interview Survey(NHIS) Food Insecurity Screener
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- 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.
Shreela V Sharma, PhD,RD,LD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
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.