Clinical trial NCT05944549: 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
Overall status: RECRUITING
Phase: NA
Conditions: Weight Loss
Keywords: weight loss
financial coaching
Cognitive functioning
metabolic functioning
psychosocial measures
health behaviors
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Bank of America Foundation
First posted: 2023-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Percent weight loss
timeFrame: From baseline to 3 months
measure: Percent weight loss
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Change in cognitive functioning as assessed by the Flanker Inhibitory test for inhibitory control
timeFrame: Baseline, 3 months, 6 months
measure: Change in cognitive functioning as assessed by the List Sorting Working Memory Test for working memory
timeFrame: Baseline, 3 months, 6 months
measure: Change in cognitive functioning as assessed by the Dimensional Change Card Sort Test (DCCS) for flexible shifting
timeFrame: Baseline, 3 months, 6 months
measure: Change in cognitive functioning as assessed by the Pattern Comparison Processing Speed Test for processing speed
timeFrame: Baseline, 3 months, 6 months
measure: Change in lipid levels
timeFrame: Baseline, 6 months
measure: Change in HbA1C
timeFrame: Baseline, 6 months
measure: Change in fasting plasma glucose (FPG)
timeFrame: Baseline, 6 months
measure: Change in diastolic blood pressure
timeFrame: Baseline, 3 months, 6 months
measure: Change in systolic blood pressure
timeFrame: Baseline, 3 months, 6 months
measure: Change in financial Stress as assessed by the Financial Stress Questionnaire
timeFrame: Baseline, 3 months, 6 months
measure: Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (affordability of household items)
timeFrame: Baseline, 3 months, 6 months
measure: Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (difficulty paying bills)
timeFrame: Baseline, 3 months, 6 months
measure: Change in mental health as assessed by the Fast Track Project Financial Stress Questionnaire (money remaining at end of month)
timeFrame: Baseline, 3 months, 6 months
measure: Change in stress as assessed by the Perceived Stress Scale (PSS)
timeFrame: Baseline, 3 months, 6 months
measure: Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD7)
timeFrame: Baseline, 3 months, 6 months
measure: Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 3 months, 6 months
measure: Change in quality of life as assessed by the Center for Disease Control (CDC)Population Well-Being Survey
timeFrame: Baseline, 3 months, 6 months
measure: Change in quality of life as assessed by the Short-Form 12 (SF-12)
timeFrame: Baseline, 3 months, 6 months
measure: Change in quality of life as assessed by the Subjective Happiness Scale (SHS)
timeFrame: Baseline, 3 months, 6 months
measure: Change in quality of life as assessed by the Satisfaction with Life Scale (SWLS)
timeFrame: Baseline, 3 months, 6 months
measure: Change in health behaviors as assessed by the NCI Automated 24-hour Dietary Assessment (ASA24) to analyze diet patterns
timeFrame: Baseline, 3 months, 6 months
measure: Change in physical activity as assessed by the School Physical Activity and Nutrition (SPAN) survey
timeFrame: Baseline, 3 months, 6 months
measure: Change in sedentary behavior as assessed by the School Physical Activity and Nutrition (SPAN) survey
timeFrame: Baseline, 3 months, 6 months
measure: Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index(PSQI)
timeFrame: Baseline, 3 months, 6 months
measure: Change in food security as assessed by the National Health Interview Survey(NHIS) Food Insecurity Screener
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shreela V Sharma, PhD,RD,LD
role: PRINCIPAL_INVESTIGATOR
References: