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Koa Family: California's Obesity Prevention Project

Primary Purpose

Weight Loss, Diet Habit, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Koa Family
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Loss focused on measuring Nutrition

Eligibility Criteria

18 Years - 47 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • UC Davis Institute for Population Health Improvement

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Other

Arm Label

RCT Intervention

RCT Control

Exploratory

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Body Mass Index (kg/m2)
Objectively measured

Secondary Outcome Measures

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

Full Information

First Posted
July 17, 2018
Last Updated
July 22, 2020
Sponsor
University of California, Davis
Collaborators
California Department of Health Services, United States Department of Agriculture (USDA), California Department of Social Services, CAL FIRE
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1. Study Identification

Unique Protocol Identification Number
NCT03605888
Brief Title
Koa Family: California's Obesity Prevention Project
Official Title
Koa Family: A Study of Improving Diet, Physical Activity, Weight, and Well-being Among Low-income Mothers in California
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
California Department of Health Services, United States Department of Agriculture (USDA), California Department of Social Services, CAL FIRE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Diet Habit, Physical Activity, Overweight and Obesity
Keywords
Nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RCT Intervention
Arm Type
Experimental
Arm Description
Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the Koa Family. intervention
Arm Title
RCT Control
Arm Type
No Intervention
Arm Description
Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the control group.
Arm Title
Exploratory
Arm Type
Other
Arm Description
Normal-weight mothers (BMI 18.5-24.9 kg/m2) assigned to the Koa Family intervention.
Intervention Type
Behavioral
Intervention Name(s)
Koa Family
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Mass Index (kg/m2)
Description
Objectively measured
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in diet quality
Description
Fruit and vegetable consumption and other indicators calculated from 24-hour dietary recall
Time Frame
12 months
Title
Change in physical activity
Description
Self-report moderate-intensity equivalent minutes per week calculated from the BRFSS Physical Activity Rotating Core questionnaire
Time Frame
12 months
Title
Change in health-related quality of life
Description
Summary score from SF-36v2 instrument
Time Frame
12 months
Title
Cost effectiveness
Description
Dollars per change in BMI and quality-adjusted life-year (QALY)
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desiree R Backman, DrPH, MS, RD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth W Kizer, MD, MPH
Organizational Affiliation
UC Davis
Official's Role
Study Director
Facility Information:
Facility Name
UC Davis Institute for Population Health Improvement
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Koa Family: California's Obesity Prevention Project

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