Koa Family: California's Obesity Prevention Project

NCT ID: NCT03605888

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-16
• Study Completion Date: 2020-06-26

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

RCT Intervention

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

Group Type: EXPERIMENTAL

Koa Family

Intervention Type: BEHAVIORAL

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.

RCT Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exploratory

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

Group Type: OTHER

Koa Family

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 47 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

California Department of Health Services

OTHER

Sponsor Role: collaborator

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

California Department of Social Services

OTHER_GOV

Sponsor Role: collaborator

CAL FIRE

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Desiree R Backman, DrPH, MS, RD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Kenneth W Kizer, MD, MPH

Role: STUDY_DIRECTOR

UC Davis

Locations

UC Davis Institute for Population Health Improvement

Sacramento, California, United States

Countries

United States

Other Identifiers

2017-088

Identifier Type: OTHER

Identifier Source: secondary_id

1229056

Identifier Type: -

Identifier Source: org_study_id