Koa Family: California's Obesity Prevention Project
- Conditions
- Physical ActivityWeight LossOverweight and ObesityDiet Habit
- Interventions
- Behavioral: Koa Family
- Registration Number
- NCT03605888
- Lead Sponsor
- University of California, Davis
- Brief Summary
The purpose of this study is to learn if a new whole-person lifestyle program improves the health of low-income mothers.
- Detailed Description
This study will employ a randomized controlled trial (RCT) design to test a newly developed obesity reduction program, Koa Family, among overweight or obese mothers. An exploratory, uncontrolled study will assess its acceptance among normal-weight mothers.
Koa Family consists of a 6-month whole-person lifestyle program (WPLP) combined with text messaging and social media support and the opportunity to take part in a neighborhood tree planting campaign. This multi-pronged program is intended to reduce weight in the short-term while building self-empowerment and connections to community resources so that participants can sustain long-term weight loss.
Koa Family will be implemented in select communities in Yolo and Sacramento counties, California. Overweight or obese study participants will be randomized to either an intervention or control group; all normal-weight participants will be assigned to the intervention. All participants will complete a survey and have their height and weight measured at baseline and 3-, 6-, 9- and 12-month follow-up. Intervention participants will also take part in a focus group at the 3-month midpoint of the intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 149
- Comfortable speaking and reading English
- Primary caregiver for ≥1 child, aged 3-17, who lives at home
- Living in a low-income household (at or below 185% of the Federal Poverty Level)
- Living in the study site catchment area
- Ability to receive and send text messages
- BMI ≥ 25 kg/m2 for RCT study
- BMI ≥18.5 and <25 kg/m2 for exploratory study
- Pregnant
- Breastfeeding
- Within 2 years postpartum
- Life-threatening illness
- Institutionalization (i.e., not free-living in the community)
- Moderate to severe mental illness
- Receiving nutrition therapy from a health or health care provider (licensed or unlicensed)
- Had or are considering bariatric surgery
- Medically diagnosed eating disorder
- Taking medication that affects weight
- Thyroid disease
- Type 1 or Type 2 diabetes without medical clearance from the participant's physician
- Plans to move away from study site catchment area during the one-year study period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RCT Intervention Koa Family Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the Koa Family. intervention Exploratory Koa Family Normal-weight mothers (BMI 18.5-24.9 kg/m2) assigned to the Koa Family intervention.
- Primary Outcome Measures
Name Time Method Change in Body Mass Index (kg/m2) 12 months Objectively measured
- Secondary Outcome Measures
Name Time Method Change in health-related quality of life 12 months Summary score from SF-36v2 instrument
Cost effectiveness 12 months Dollars per change in BMI and quality-adjusted life-year (QALY)
Change in physical activity 12 months Self-report moderate-intensity equivalent minutes per week calculated from the BRFSS Physical Activity Rotating Core questionnaire
Change in diet quality 12 months Fruit and vegetable consumption and other indicators calculated from 24-hour dietary recall
Trial Locations
- Locations (1)
UC Davis Institute for Population Health Improvement
🇺🇸Sacramento, California, United States