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

Primary Purpose

Weight Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial coaching using TrustPlus
Brighter Bites
Noom
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Loss focused on measuring weight loss, financial coaching, Cognitive functioning, metabolic functioning, psychosocial measures, health behaviors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced Intervention group

lifestyle-intervention group

Arm Description

Outcomes

Primary Outcome Measures

Percent weight loss
Average of the 2 weights will be calculated
Percent weight loss
Average of the 2 weights will be calculated

Secondary Outcome Measures

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.
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.
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.
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.
Change in lipid levels
Change in HbA1C
Change in fasting plasma glucose (FPG)
Change in diastolic blood pressure
Change in systolic blood pressure
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
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.
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.
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.
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
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
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
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.
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
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
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
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.
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
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
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.
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.

Full Information

First Posted
July 5, 2023
Last Updated
July 5, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Bank of America Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05944549
Brief Title
Financial Coaching and Lifestyle Intervention for Diabetes Prevention in Low-income Families
Official Title
Financial Coaching and Lifestyle Intervention for Diabetes Prevention in Low-income Families
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Bank of America Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
weight loss, financial coaching, Cognitive functioning, metabolic functioning, psychosocial measures, health behaviors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Intervention group
Arm Type
Experimental
Arm Title
lifestyle-intervention group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Financial coaching using TrustPlus
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brighter Bites
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Noom
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent weight loss
Description
Average of the 2 weights will be calculated
Time Frame
From baseline to 3 months
Title
Percent weight loss
Description
Average of the 2 weights will be calculated
Time Frame
From baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in cognitive functioning as assessed by the Flanker Inhibitory test for inhibitory control
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Change in cognitive functioning as assessed by the List Sorting Working Memory Test for working memory
Description
This test assesses working memory. Total score ranges from 0-26, with a higher score indicating better working memory.
Time Frame
Baseline, 3 months, 6 months
Title
Change in cognitive functioning as assessed by the Dimensional Change Card Sort Test (DCCS) for flexible shifting
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Change in cognitive functioning as assessed by the Pattern Comparison Processing Speed Test for processing speed
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Change in lipid levels
Time Frame
Baseline, 6 months
Title
Change in HbA1C
Time Frame
Baseline, 6 months
Title
Change in fasting plasma glucose (FPG)
Time Frame
Baseline, 6 months
Title
Change in diastolic blood pressure
Time Frame
Baseline, 3 months, 6 months
Title
Change in systolic blood pressure
Time Frame
Baseline, 3 months, 6 months
Title
Change in financial Stress as assessed by the Financial Stress Questionnaire
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (affordability of household items)
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (difficulty paying bills)
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (money remaining at end of month)
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Change in stress as assessed by the Perceived Stress Scale (PSS)
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD7)
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Change in quality of life as assessed by the Center for Disease Control (CDC)Population Well-Being Survey
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Change in quality of life as assessed by the Short-Form 12 (SF-12)
Description
This is a 12 item questionnaire, scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Time Frame
Baseline, 3 months, 6 months
Title
Change in quality of life as assessed by the Subjective Happiness Scale (SHS)
Description
This is a 4 item questionnaire and each is scored form 1-7, higher number indicating greater levels of happiness
Time Frame
Baseline, 3 months, 6 months
Title
Change in quality of life as assessed by the Satisfaction with Life Scale (SWLS)
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Change in health behaviors as assessed by the NCI Automated 24-hour Dietary Assessment (ASA24) to analyze diet patterns
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Change in physical activity as assessed by the School Physical Activity and Nutrition (SPAN) survey
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Change in sedentary behavior as assessed by the School Physical Activity and Nutrition (SPAN) survey
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index(PSQI)
Description
This is a 19 item questionnaire. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.
Time Frame
Baseline, 3 months, 6 months
Title
Change in food security as assessed by the National Health Interview Survey(NHIS) Food Insecurity Screener
Description
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.
Time Frame
Baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shreela V Sharma, PhD,RD,LD
Phone
713-500-9344
Email
Shreela.V.Sharma@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jemima C John
Phone
713-500-9000
Email
Jemima.John@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shreela V Sharma, PhD,RD,LD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shreela V Sharma, Ph.D., R.D., L.D
Phone
713-500-9344
Email
Shreela.V.Sharma@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Jemima C John
Phone
713-500-9000
Email
Jemima.John@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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