Koa Family: California's Obesity Prevention Project

University of California (UC) Davis

Status: Completed

Conditions: Weight Loss; Physical Activity; Diet Habit; Overweight and Obesity

Treatments: Behavioral: Koa Family

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03605888

2017-088 (Other Identifier)

1229056

Details and patient eligibility

About

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

Full 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.

Enrollment: 149 patients

Sex: Female

Ages: 18 to 47 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 3 patient groups

RCT Intervention

Experimental group

Description:

Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the Koa Family. intervention

Treatment:

Behavioral: Koa Family

RCT Control

No Intervention group

Description:

Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the control group.

Exploratory

Other group

Description:

Normal-weight mothers (BMI 18.5-24.9 kg/m2) assigned to the Koa Family intervention.

Treatment:

Behavioral: Koa Family