NCT03605888

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

August 16, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

July 17, 2018

Last Update Submit

July 22, 2020

Conditions

Weight LossDiet HabitPhysical ActivityOverweight and Obesity

Keywords

Nutrition

Outcome Measures

Primary Outcomes (1)

  • Change in Body Mass Index (kg/m2)

    Objectively measured

    12 months

Secondary Outcomes (4)

  • Change in diet quality

    12 months

  • Change in physical activity

    12 months

  • Change in health-related quality of life

    12 months

  • Cost effectiveness

    12 months

Study Arms (3)

RCT Intervention

EXPERIMENTAL

Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the Koa Family. intervention

Behavioral: Koa Family

RCT Control

NO INTERVENTION

Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the control group.

Exploratory

OTHER

Normal-weight mothers (BMI 18.5-24.9 kg/m2) assigned to the Koa Family intervention.

Behavioral: Koa Family

Interventions

Koa FamilyBEHAVIORAL

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.

ExploratoryRCT Intervention

Eligibility Criteria

Age18 Years - 47 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Institute for Population Health Improvement

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Weight LossFeeding BehaviorMotor ActivityOverweightObesity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehaviorOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Desiree R Backman, DrPH, MS, RD

    UC Davis

    PRINCIPAL INVESTIGATOR

  • Kenneth W Kizer, MD, MPH

    UC Davis

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 30, 2018

Study Start

August 16, 2018

Primary Completion

June 26, 2020

Study Completion

June 26, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)