Koa Family: California's Obesity Prevention Project

Study Overview
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Brief Summary
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The purpose of this study is to learn if a new whole-person lifestyle program improves the health of low-income mothers.

Detailed Description
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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.

Official Title
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Koa Family: A Study of Improving Diet, Physical Activity, Weight, and Well-being Among Low-income Mothers in California

Conditions
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Weight Loss, Diet Habit, Physical Activity, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Koa Family


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RCT Intervention<br>Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the Koa Family. intervention | Behavioral: Koa Family<br>* Koa Family is a 6-month program consisting of a whole-person lifestyle program (WPLP) combined with text messaging and social media support and a neighborhood tree planting campaign. The WPLP will bring groups of 8 to 10 mothers living in the same community together for 22 weekly 90-minute support sessions. Each session will cover a topic on whole-person living, including healthy eating, physical activity, stress reduction, coping, and well-being. Participants will receive brief text messages on their cell phones to encourage healthy lifestyle choices. Participants also will be invited to join a secret Facebook group where they can support one another in healthy lifestyle change. Finally, participants will have an opportunity to take part in a neighborhood tree planting campaign.<br>|
| No Intervention: RCT Control<br>Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the control group. | |
| Other: Exploratory<br>Normal-weight mothers (BMI 18.5-24.9 kg/m2) assigned to the Koa Family intervention. | Behavioral: Koa Family<br>* Koa Family is a 6-month program consisting of a whole-person lifestyle program (WPLP) combined with text messaging and social media support and a neighborhood tree planting campaign. The WPLP will bring groups of 8 to 10 mothers living in the same community together for 22 weekly 90-minute support sessions. Each session will cover a topic on whole-person living, including healthy eating, physical activity, stress reduction, coping, and well-being. Participants will receive brief text messages on their cell phones to encourage healthy lifestyle choices. Participants also will be invited to join a secret Facebook group where they can support one another in healthy lifestyle change. Finally, participants will have an opportunity to take part in a neighborhood tree planting campaign.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index (kg/m2) | Objectively measured | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diet quality | Fruit and vegetable consumption and other indicators calculated from 24-hour dietary recall | 12 months | 
| Change in physical activity | Self-report moderate-intensity equivalent minutes per week calculated from the BRFSS Physical Activity Rotating Core questionnaire | 12 months | 
| Change in health-related quality of life | Summary score from SF-36v2 instrument | 12 months | 
| Cost effectiveness | Dollars per change in BMI and quality-adjusted life-year (QALY) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition