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Completed

NCT Number: NCT03605888

Koa Family: California's Obesity Prevention Project

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

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Key information

Conditions

Weight Loss Behavior Behavior, Animal Body Weight Body Weight Changes Diet Habit Feeding Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

18 year–47 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Institute for Population Health Improvement

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Koa Family

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.

Primary outcomes

  1. Change in Body Mass Index (kg/m2)

    Time frame: 12 months

    Objectively measured

Secondary outcomes

  1. Change in diet quality

    Time frame: 12 months

    Fruit and vegetable consumption and other indicators calculated from 24-hour dietary recall

  2. Change in physical activity

    Time frame: 12 months

    Self-report moderate-intensity equivalent minutes per week calculated from the BRFSS Physical Activity Rotating Core questionnaire

  3. Change in health-related quality of life

    Time frame: 12 months

    Summary score from SF-36v2 instrument

  4. Cost effectiveness

    Time frame: 12 months

    Dollars per change in BMI and quality-adjusted life-year (QALY)

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • CAL FIRE
  • California Department of Health Services
  • California Department of Social Services
  • United States Department of Agriculture (USDA)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2018
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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