NCT05944549CompletedNot Applicable
Financial Coaching and Lifestyle Intervention for Diabetes Prevention in Low-income Families
The University of Texas Health Science Center, Houston2 sites in 1 country58 target enrollmentStarted: May 12, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Percent weight loss
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Percent weight loss
Time Frame: From baseline to 6 months
Average of the 2 weights will be calculated
Secondary Outcomes
- 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)
- Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD7)(Baseline, 3 months, 6 months)
- Change in health behaviors as assessed by the NCI Automated 24-hour Dietary Assessment (ASA24) to analyze diet patterns(Baseline, 3 months, 6 months)
- Change in cognitive functioning as assessed by the Flanker Inhibitory test for inhibitory control(Baseline, 3 months, 6 months)
- Change in cognitive functioning as assessed by the Pattern Comparison Processing Speed Test for processing speed(Baseline, 3 months, 6 months)
- Change in financial Stress as assessed by the Financial Stress Questionnaire(Baseline, 3 months, 6 months)
- Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (affordability of household items)(Baseline, 3 months, 6 months)
- Change in sedentary behavior as assessed by the School Physical Activity and Nutrition (SPAN) survey(Baseline, 3 months, 6 months)
- Change in cognitive functioning as assessed by the List Sorting Working Memory Test for working memory(Baseline, 3 months, 6 months)
- Change in cognitive functioning as assessed by the Dimensional Change Card Sort Test (DCCS) for flexible shifting(Baseline, 3 months, 6 months)
- Change in HbA1C(Baseline, 6 months)
- Change in quality of life as assessed by the Subjective Happiness Scale (SHS)(Baseline, 3 months, 6 months)
- 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)
- Change in quality of life as assessed by the Center for Disease Control (CDC)Population Well-Being Survey(Baseline, 3 months, 6 months)
- Change in quality of life as assessed by the Short-Form 12 (SF-12)(Baseline, 3 months, 6 months)
- Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index(PSQI)(Baseline, 3 months, 6 months)
- Change in stress as assessed by the Perceived Stress Scale (PSS)(Baseline, 3 months, 6 months)
- Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)(Baseline, 3 months, 6 months)
- Change in quality of life as assessed by the Satisfaction with Life Scale (SWLS)(Baseline, 3 months, 6 months)
- Change in physical activity as assessed by the School Physical Activity and Nutrition (SPAN) survey(Baseline, 3 months, 6 months)
- Change in food security as assessed by the National Health Interview Survey(NHIS) Food Insecurity Screener(Baseline, 3 months, 6 months)
Investigators
Shreela V Sharma
Professor
The University of Texas Health Science Center, Houston
Study Sites (2)
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