Financial Coaching and Lifestyle Intervention for Diabetes Prevention in Low-income Families
- Conditions
- Weight Loss
- Interventions
- Behavioral: Financial coaching using TrustPlusBehavioral: NoomBehavioral: Brighter Bites
- Registration Number
- NCT05944549
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Intervention group Financial coaching using TrustPlus - lifestyle-intervention group Noom - Enhanced Intervention group Brighter Bites - lifestyle-intervention group Brighter Bites - Enhanced Intervention group Noom -
- Primary Outcome Measures
Name Time Method Percent weight loss From baseline to 6 months Average of the 2 weights will be calculated
- Secondary Outcome Measures
Name Time Method Change in fasting plasma glucose (FPG) Baseline, 6 months Change in lipid levels Baseline, 6 months Change in diastolic blood pressure Baseline, 3 months, 6 months Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (difficulty paying bills) Baseline, 3 months, 6 months 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 anxiety as assessed by the Generalized Anxiety Disorder (GAD7) Baseline, 3 months, 6 months 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 health behaviors as assessed by the NCI Automated 24-hour Dietary Assessment (ASA24) to analyze diet patterns Baseline, 3 months, 6 months 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 cognitive functioning as assessed by the Flanker Inhibitory test for inhibitory control Baseline, 3 months, 6 months 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 Pattern Comparison Processing Speed Test for processing speed Baseline, 3 months, 6 months 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 financial Stress as assessed by the Financial Stress Questionnaire Baseline, 3 months, 6 months 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 organizationsChange in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (affordability of household items) Baseline, 3 months, 6 months 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 sedentary behavior as assessed by the School Physical Activity and Nutrition (SPAN) survey Baseline, 3 months, 6 months 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 moviesChange in cognitive functioning as assessed by the List Sorting Working Memory Test for working memory Baseline, 3 months, 6 months 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 Baseline, 3 months, 6 months 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 HbA1C Baseline, 6 months Change in quality of life as assessed by the Subjective Happiness Scale (SHS) Baseline, 3 months, 6 months This is a 4 item questionnaire and each is scored form 1-7, higher number indicating greater levels of happiness
Change in systolic blood pressure 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) Baseline, 3 months, 6 months 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 quality of life as assessed by the Center for Disease Control (CDC)Population Well-Being Survey Baseline, 3 months, 6 months 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) Baseline, 3 months, 6 months 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 sleep as assessed by the Pittsburgh Sleep Quality Index(PSQI) Baseline, 3 months, 6 months 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 stress as assessed by the Perceived Stress Scale (PSS) Baseline, 3 months, 6 months 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 depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) Baseline, 3 months, 6 months 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 Satisfaction with Life Scale (SWLS) Baseline, 3 months, 6 months 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 physical activity as assessed by the School Physical Activity and Nutrition (SPAN) survey Baseline, 3 months, 6 months 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 playChange in food security as assessed by the National Health Interview Survey(NHIS) Food Insecurity Screener Baseline, 3 months, 6 months 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.
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States