Clinical trial NCT03605888: Koa Family: California's Obesity Prevention Project
Official title: Koa Family: A Study of Improving Diet, Physical Activity, Weight, and Well-being Among Low-income Mothers in California
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Diet Habit
Physical Activity
Overweight and Obesity
Keywords: Nutrition
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: California Department of Health Services
name: United States Department of Agriculture (USDA)
name: California Department of Social Services
name: CAL FIRE
First posted: 2018-07-30
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Mass Index (kg/m2)
timeFrame: 12 months
Secondary outcomes:
measure: Change in diet quality
timeFrame: 12 months
measure: Change in physical activity
timeFrame: 12 months
measure: Change in health-related quality of life
timeFrame: 12 months
measure: Cost effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Institute for Population Health Improvement
state: California
Study officials:
affiliation: UC Davis
name: Desiree R Backman, DrPH, MS, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Davis
name: Kenneth W Kizer, MD, MPH
role: STUDY_DIRECTOR
References: