Koa Family: California's Obesity Prevention Project
Atslēgvārdi
Abstrakts
Apraksts
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.
Datumi
| Pēdējoreiz pārbaudīts: | 06/30/2020 |
| Pirmais iesniegtais: | 07/16/2018 |
| Paredzētā reģistrācija iesniegta: | 07/25/2018 |
| Pirmais izlikts: | 07/29/2018 |
| Pēdējais atjauninājums iesniegts: | 07/21/2020 |
| Pēdējā atjaunināšana ievietota: | 07/22/2020 |
| Faktiskais studiju sākuma datums: | 08/15/2018 |
| Paredzamais primārās pabeigšanas datums: | 06/25/2020 |
| Paredzamais pētījuma pabeigšanas datums: | 06/25/2020 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Behavioral: Koa Family
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Experimental: RCT Intervention Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the Koa Family. intervention | |
| No Intervention: RCT Control Overweight or obese (BMI ≥ 25 kg/m2) participants randomized to the control group. | |
| Other: Exploratory Normal-weight mothers (BMI 18.5-24.9 kg/m2) assigned to the Koa Family intervention. |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | Female |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | 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 |
Rezultāts
Primārie rezultāti
1. Change in Body Mass Index (kg/m2) [12 months]
Sekundārie iznākuma mērījumi
1. Change in diet quality [12 months]
2. Change in physical activity [12 months]
3. Change in health-related quality of life [12 months]
4. Cost effectiveness [12 months]
