Koa Family Study--A Community-Based Intervention to Improve Health and Well-Being
Condition: Obesity; Overweight; Diet, Healthy; Social Interaction; Weight Loss
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Wholehearted living touches every aspect of life, from eating nourishing foods, to enjoying
      enough physical activity, to cultivating relationships that support healthy choices, to
      joining with neighbors to stand up for positive changes, and more. Unfortunately, for many
      low-income Californians, the idea of wholehearted living is an aspiration and not a reality.
      Koa Family: Strong, Healthy, Whole is an approach designed to make wholehearted living
      available for all.

      The Approach Koa Family is a 4-month journey to establish "micro-communities" of women
      supporting one another- mind, body, and spirit. The foundation of this approach is a new,
      custom-designed, online Whole Health Program (WHP) that addresses healthy eating, physical
      activity, and weight management within the context of wholehearted living. Low-income women
      and a lifestyle coach will meet weekly in a virtual platform to learn, experience, grow, and
      thrive as they reach their diet, physical activity, and weight management goals.

      Participants in the WHP will receive additional encouragement and access to local resources
      through a private and secure Facebook group. The group will provide a place for women to
      continue their wholehearted health journeys beyond the weekly meetings. Koa Family
      participants also will be invited to take part in a neighborhood tree planting campaign to
      create real, long-lasting, healthy changes to the environment in which they live.

      The Study Koa Family, with WHP at its core, is the product of extensive formative research
      both nationally and within low-income California communities. Koa Family will be introduced
      in Sacramento County in February 2021. It will be evaluated for effectiveness among 120
      low-income, Supplemental Nutrition Assistance Program (SNAP)-Ed eligible women using a
      randomized controlled trial study design, the gold standard for assessing effectiveness of an
      intervention. Outcomes include changes in Body Mass Index, diet, and physical activity
      measured at 4 and 6 months from baseline. An economic analysis will assess the
      cost-effectiveness of Koa Family, while qualitative methods will identify mediating factors
      related to the study outcomes.

      Funding Koa Family is a project of the Population Health Group at the University of
      California, Davis, Center for Healthcare Policy and Research. Funding is provided by the
      United States Department of Agriculture Supplemental Nutrition Assistance Program-Education
      and the California Department of Forestry and Fire Protection (CalFIRE).
    

Detailed description: 
      The Koa Family Study is a randomized controlled trial testing a 17-week intervention, the Koa
      Family Program (KFP), consisting of three components: (1) the Whole Health Program (WHP)-a
      weekly, online group session facilitated by a health coach using the Zoom platform; (2)
      social media support including texting of health messages and a private Facebook group; and
      (3) a community empowerment arm designed around tree planting. The KFP addresses well-being
      from physical, mental, and social health perspectives. The program is intended to increase
      weight loss while fostering self-empowerment and connections to community resources to help
      sustain long-term weight management.

      This study will test the following hypotheses:

        1. Intervention participants, consisting of low-income overweight or obese women living in
           urban communities, receiving the KFP will have greater average weight loss and reduction
           in body mass index (BMI) than participants in the control group (who do not participate
           in the KFP);

        2. KFP participants will show greater improvements in dietary practices compared with
           participants in the control group;

        3. KFP participants will have greater increases in physical activity compared with control
           group participants;

        4. KFP participants will have greater improvements in measures of well-being) compared with
           control group participants;

        5. There will be a dose-response effect where greater engagement with the components of the
           KFP will be associated with larger improvements in the above endpoints (weight, diet,
           physical activity, and well-being).

      Study design. The primary study will employ a prospective, randomized controlled trial (RCT)
      design. One hundred twenty eligible participants will be assigned to either the intervention
      (n=60) or control (n=60) group.

      Intervention. The intervention group (n=60) will participate in the 17-week, KFP that
      supports physical, mental, and social well-being. It consists of: (1) theWHP-a weekly, online
      group session facilitated by a health coach using the Zoom platform; (2) social media support
      including texting of health messages and a private Facebook group; and (3) a community
      empowerment arm designed around tree planting.

      The WHP is a small group-focused intervention designed to build "micro-communities" of
      mothers supporting one another in healthy living. Groups of 5-10 women living in the same
      community will meet online for 75 minutes weekly via the Zoom platform, for a total of 17
      sessions. Each weekly session will cover a topic on whole-person living, including healthy
      eating, physical activity, weight management, coping, and resilience. The content of the WHP
      is based, in part, on the Centers for Disease Control and Prevention's National Diabetes
      Prevention Program (PT2) and Family Hui, a peer-led, women's group program to increase
      positive parenting skills and help families thrive.

      For social media support, the intervention participants will receive brief text messages on
      their cell phones to encourage healthy lifestyle choices and connect to supportive community
      events and resources. EZTexting will be used to send text messages to participants. The
      participants also will be invited to join a private Facebook community, linked to each WHP
      group.

      The principles and practice for tree planting and stewardship will be taught within the WHP
      sessions. If public health policy at the time, relating to managing Coronavirus Disease
      (COVID)-19 permits, participants may choose to participate in community tree plantings while
      complying with public health directives.

      The control group participants will be enrolled for study measurements only and after the
      intervention period, will receive information based on what is proven effective in the RCT.
      This information will be delivered in a series of three webinars delivered after the last
      study data are collected at 25 weeks after baseline.

      Data Collection. All participants will be asked to complete a phone-based, questionnaire
      administered by trained research staff. It will take about 50 minutes to complete the
      questionnaire. Questions will cover diet, physical activity, and well-being. The
      questionnaire will be administered at baseline, at week 18 after completion of the 17-week
      intervention, and at week 26 of the study.

      At about week 8, an online focus group will be conducted as part of one of the sessions to
      qualitatively assess participants' experiences with the KFP.

      Weight will be collected, daily, through a research-quality, Bluetooth-enabled scale that can
      transmit participant weights via the Internet to a secure server.
    

Intervention name(s): Whole Health Program
Intervention type(s): Behavioral
Intervention description(s): A mind-body-spirit intervention to improve health and well-being including weight loss.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Prevention