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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03605888
Other study ID # 1229056
Secondary ID 2017-088
Status Completed
Phase N/A
First received
Last updated
Start date August 16, 2018
Est. completion date June 26, 2020

Study information

Verified date July 2020
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date June 26, 2020
Est. primary completion date June 26, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 47 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Koa Family
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.

Locations

Country Name City State
United States UC Davis Institute for Population Health Improvement Sacramento California

Sponsors (5)

Lead Sponsor Collaborator
University of California, Davis CAL FIRE, California Department of Health Services, California Department of Social Services, United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Body Mass Index (kg/m2) Objectively measured 12 months
Secondary Change in diet quality Fruit and vegetable consumption and other indicators calculated from 24-hour dietary recall 12 months
Secondary Change in physical activity Self-report moderate-intensity equivalent minutes per week calculated from the BRFSS Physical Activity Rotating Core questionnaire 12 months
Secondary Change in health-related quality of life Summary score from SF-36v2 instrument 12 months
Secondary Cost effectiveness Dollars per change in BMI and quality-adjusted life-year (QALY) 12 months
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