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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944549
• Other study ID #: HSC-SPH-23-0002
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Shreela V Sharma, PhD,RD,LD
• Phone: 713-500-9344
• Email: Shreela.V.Sharma[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Weight Loss

Intervention

Behavioral:
• Financial coaching using TrustPlus
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 Bites
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.
• Noom
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Bank of America Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent weight loss	Average of the 2 weights will be calculated	From baseline to 3 months
Primary	Percent weight loss	Average of the 2 weights will be calculated	From baseline to 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	Change in lipid levels		Baseline, 6 months
Secondary	Change in HbA1C		Baseline, 6 months
Secondary	Change in fasting plasma glucose (FPG)		Baseline, 6 months
Secondary	Change in diastolic blood pressure		Baseline, 3 months, 6 months
Secondary	Change in systolic blood pressure		Baseline, 3 months, 6 months
Secondary	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	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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	Baseline, 3 months, 6 months
Secondary	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	Baseline, 3 months, 6 months
Secondary	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	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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	Baseline, 3 months, 6 months
Secondary	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	Baseline, 3 months, 6 months
Secondary	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	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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	Baseline, 3 months, 6 months
Secondary	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	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months