Koa Family: California's Obesity Prevention Project

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

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

Study Overview

• Status: Completed
• Conditions: Physical Activity; Weight Loss; Overweight and Obesity; Diet Habit
• Intervention / Treatment: Behavioral: Koa Family

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.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • UC Davis Institute for Population Health Improvement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RCT Intervention; Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the Koa Family. intervention	Behavioral: Koa Family; 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.
No Intervention: RCT Control; Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the control group.
Other: Exploratory; Normal-weight mothers (BMI 18.5-24.9 kg/m2) assigned to the Koa Family intervention.	Behavioral: Koa Family; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: United States Department of Agriculture (USDA); California Department of Health Services; California Department of Social Services; CAL FIRE
• Investigators: Principal Investigator: Desiree R Backman, DrPH, MS, RD, UC Davis; Study Director: Kenneth W Kizer, MD, MPH, UC Davis

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2018
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Nutrition
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Obesity; Weight Loss; Overweight
• Other Study ID Numbers: 1229056; 2017-088 (Other Identifier: The Committee for the Protection of Human Subjects)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No