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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-088 | Other Identifier | The Committee for the Protection of Human Subjects |
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| Name | Class |
|---|---|
| California Department of Health Services | OTHER |
| United States Department of Agriculture (USDA) | FED |
| California Department of Social Services | OTHER_GOV |
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The purpose of this study is to learn if a new whole-person lifestyle program improves the health of low-income mothers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RCT Intervention | Experimental | Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the Koa Family. intervention |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Koa Family | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (kg/m2) | Objectively measured | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in diet quality | Fruit and vegetable consumption and other indicators calculated from 24-hour dietary recall | 12 months |
| Change in physical activity | Self-report moderate-intensity equivalent minutes per week calculated from the BRFSS Physical Activity Rotating Core questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Desiree R Backman, DrPH, MS, RD | UC Davis | Principal Investigator |
| Kenneth W Kizer, MD, MPH | UC Davis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Institute for Population Health Improvement | Sacramento | California | 95816 | United States |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D005247 | Feeding Behavior |
| D009043 | Motor Activity |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| CAL FIRE |
| OTHER |
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| 12 months |
| Change in health-related quality of life | Summary score from SF-36v2 instrument | 12 months |
| Cost effectiveness | Dollars per change in BMI and quality-adjusted life-year (QALY) | 12 months |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |