NCT04662593: KFS

Koa Family Study--A Community-Based Intervention to Improve Health and Well-Being

Completed NA Last updated 11 October 2021

What this trial tests

NA trial testing Whole Health Program in Obesity in 70 participants. Completed in 23 September 2021.

Timeline

4 January 2021

Primary endpoint
13 September 2021

23 September 2021

Quick facts

Lead sponsor	University of California, Davis
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	70
Start date	4 January 2021
Primary completion	13 September 2021
Estimated completion	23 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Whole Health Program

Conditions studied

• Obesity — all drugs for Obesity →
• Overweight — all drugs for Overweight →
• Diet, Healthy — all drugs for Diet, Healthy →
• Social Interaction — all drugs for Social Interaction →

Sponsor

University of California, Davis

Who can join

Adults 21 to 45, female only, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cost-Effectiveness Analysis of a Community-Based Telewellness Weight Loss Program.
   Hoch JS, Kohatsu ND, Fleuret J, Backman DR. · · 2024 · cited 2× · PMID 38304023 · DOI 10.1016/j.focus.2024.100182