Koa Family: California's Obesity Prevention Project

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605888
• Other study ID #: 1229056
• Secondary ID: 2017-088
• Status: Completed
• Phase: N/A
• Start date: August 16, 2018
• Est. completion date: June 26, 2020

Study information

• Verified date: July 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: June 26, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 47 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Habit
• Obesity
• Overweight
• Overweight and Obesity
• Physical Activity
• Weight Loss

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.

Locations

Country	Name	City	State
United States	UC Davis Institute for Population Health Improvement	Sacramento	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Davis	CAL FIRE, California Department of Health Services, California Department of Social Services, United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index (kg/m2)	Objectively measured	12 months
Secondary	Change in diet quality	Fruit and vegetable consumption and other indicators calculated from 24-hour dietary recall	12 months
Secondary	Change in physical activity	Self-report moderate-intensity equivalent minutes per week calculated from the BRFSS Physical Activity Rotating Core questionnaire	12 months
Secondary	Change in health-related quality of life	Summary score from SF-36v2 instrument	12 months
Secondary	Cost effectiveness	Dollars per change in BMI and quality-adjusted life-year (QALY)	12 months