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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04662593
Recruitment Status : Completed
First Posted : December 10, 2020
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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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).


Condition or disease Intervention/treatment Phase
Obesity Overweight Diet, Healthy Social Interaction Weight Loss Behavioral: Whole Health Program Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Koa Family Study--A Community-Based Intervention to Improve Health and Well-Being
Actual Study Start Date : January 4, 2021
Actual Primary Completion Date : September 13, 2021
Actual Study Completion Date : September 23, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group

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
A mind-body-spirit intervention to improve health and well-being including weight loss.
No Intervention: Control Group
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Weight at 4 Months [ Time Frame: Difference in weight between baseline and 4 months ]
    Weight (kg) measured with an electronic scale

  2. Change from Baseline Weight at 6 Months [ Time Frame: Difference in weight between baseline and 6 months ]
    Weight (kg) measured with an electronic scale

  3. Change from Baseline Body Mass Index (BMI) at 4 Months [ Time Frame: Difference in BMI between baseline and 4 months ]
    weight (kg)/height (m) x height (m)

  4. Change from Baseline Body Mass Index (BMI) at 6 Months [ Time Frame: Difference in BMI between baseline and 6 months ]
    weight (kg)/height (m) x height (m)

  5. Change from Baseline Diet at 4 Months [ Time Frame: Difference in diet between baseline and 4 months ]
    Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet

  6. Change from Baseline Diet at 6 Months [ Time Frame: Difference in diet between baseline and 6 months ]
    Measured with the Dietary Screener Questionnaire (NHANES 2009-10) to examine quality of participants' diet

  7. Change from Baseline Physical Activity (PA) at 4 Months [ Time Frame: Difference in PA between baseline and 4 months ]
    Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module

  8. Change from Baseline Physical Activity (PA) at 6 Months [ Time Frame: Difference in PA between baseline and 6 months ]
    Measured using the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance Survey Physical Activity Module

  9. Change from Baseline Health-Related Well-being at 4 Months [ Time Frame: Difference in health-related well-being between baseline and 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

  10. Change from Baseline Health-Related Well-being at 6 Months [ Time Frame: Difference in health-related well-being between baseline and 6 months ]
    Well-being and general health measured with Short Form-36v2


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female
  • 21-45 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)

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662593


Locations
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United States, California
UC Davis
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Desiree Backman, DrPH, MS, RD UC Davis Center for Healthcare Policy and Research
More Information
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Publications:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04662593    
Other Study ID Numbers: 1668154
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Body Weight Changes