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

NCT04662593 | Completed

• 1 other identifier: 1668154
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obesity; Overweight; Diet, Healthy; Social Interaction; Weight Loss

Outcome Measures

Primary Outcomes (10)

• Change from Baseline Weight at 4 Months

  Weight (kg) measured with an electronic scale

  Difference in weight between baseline and 4 months

• Change from Baseline Weight at 6 Months

  Weight (kg) measured with an electronic scale

  Difference in weight between baseline and 6 months

• Change from Baseline Body Mass Index (BMI) at 4 Months

  weight (kg)/height (m) x height (m)

  Difference in BMI between baseline and 4 months

• Change from Baseline Body Mass Index (BMI) at 6 Months

  weight (kg)/height (m) x height (m)

  Difference in BMI between baseline and 6 months

• Change from Baseline Diet at 4 Months

  Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet

  Difference in diet between baseline and 4 months

• Change from Baseline Diet at 6 Months

  Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet

  Difference in diet between baseline and 6 months

• Change from Baseline Physical Activity (PA) at 4 Months

  Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module

  Difference in PA between baseline and 4 months

• Change from Baseline Physical Activity (PA) at 6 Months

  Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module

  Difference in PA between baseline and 6 months

• Change from Baseline Health-Related Well-being at 4 Months

  Well-being and general health measured with Short Form-36v2; There are 8 sections each scored 0-100 with a high score indicating less disability

  Difference in health-related well-being between baseline and 4 months

• Change from Baseline Health-Related Well-being at 6 Months

  Well-being and general health measured with Short Form-36v2

  Difference in health-related well-being between baseline and 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group participates in a 17-week whole health program including: 1. Weekly, small group online meetings with a health coach; 2. Supportive social media including a private Facebook group and selective text messaging; 3. Exposure to community tree planting and stewardship (through live streaming or in-person if COVID-19 public health guidance at the time, permits.

Behavioral: Whole Health Program

Control Group

NO INTERVENTION

The control group participates only in questionnaire data collection at baseline, 4 months, and 6 months as well as daily weighing. Control group participants will be offered 3 web-based seminars (webinars) highlighting the effective lifestyle approaches demonstrated in the study and intervention group health education materials. The webinars and materials will be provided after the 6-month data collection which concludes the study.

Interventions

Whole Health Program BEHAVIORAL

A mind-body-spirit intervention to improve health and well-being including weight loss.

Intervention Group

Eligibility Criteria

• Age: 21 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female
• years old
• comfortable speaking and reading English (all race/ethnicities are welcomed to participate)
• living in a low-income household (at or below 185% of the Federal Poverty Level)
• living in the Sacramento area
• familiarity with Facebook, Zoom, and texting
• access to a smartphone or high-speed internet (via a tablet or computer)
• overweight or obese (BMI≥25 and \<39.9)

You may not qualify if:

• pregnancy;
• 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 during the study period.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis

Sacramento, California, 95816, United States

Location

Related Publications (2)

• Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.

  PMID: 22253363 BACKGROUND

• Abdelaal M, le Roux CW, Docherty NG. Morbidity and mortality associated with obesity. Ann Transl Med. 2017 Apr;5(7):161. doi: 10.21037/atm.2017.03.107.

  PMID: 28480197 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Desiree Backman, DrPH, MS, RD

  UC Davis Center for Healthcare Policy and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 10, 2020
• Study Start: January 4, 2021
• Primary Completion: September 13, 2021
• Study Completion: September 23, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)