Strong Futures: A Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
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|ClinicalTrials.gov Identifier: NCT03438721|
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity Health-Related Quality of Life||Behavioral: Infant obesity prevention Behavioral: Financial coaching||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Strong Futures: A Pilot Randomized Controlled Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers|
|Actual Study Start Date :||April 11, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: Infant Obesity Prevention
The infant obesity prevention arm will provide parents with education on optimal infant feeding, sleep, and screen time practices.
Behavioral: Infant obesity prevention
Parents will receive education on infant feeding, sleep, and screen time practices just after well-child visits in the first year of life. The education will be provided by a lay health educator. Parents will also receive text messages to reinforce the intervention content
Experimental: Financial Coaching
The financial coaching arm will provide parents with education on basic financial literacy topics and coaching to help parents achieve financial goals.
Behavioral: Financial coaching
Parents randomized to the financial coaching arm will receive basic education on financial topics including budgeting, savings, and managing debt as well as coaching on these topics just after well-child visits in the first year of life. Coaching will be provided by lay health educators trained in financial coaching. Parents will also receive text messages reinforcing the information learned.
- Child dietary intake [ Time Frame: 15-months ]Total child intake of sugar-sweetened-beverages and 100% fruit juice in ounces and total intake of fruits and vegetables in grams.
- Child screen time [ Time Frame: Child age 15-months ]Total minutes of daily screen time
- Parent health-related quality of life [ Time Frame: Child age 15-months ]Assessed by the PROMIS-10. The Patient Reported Outcome Measurement Information System Global Short Form 10 (PROMIS-10) is a ten-item scale measuring health related quality of life with subscales for physical and mental health. Raw overall total PROMIS-10 scale scores range from 10-50, with sub-scale T-scores that range from 16-67 for physical health and 21-68 for mental health. For all PROMIS-10 total raw and sub-scale scores, higher scores indicate better health-related quality of life.
- Child anthropometrics [ Time Frame: Child ages 6-months, 12-months, 15-months and 24-months ]World Health Organization Weight-for-length z-score
- Parent financial stress [ Time Frame: Child age 15-months ]Consumer Financial Protection Bureau Financial Well-Being Scale. The Consumer Financial Protection Bureau Financial Well Being Questionnaire (Short Form, CFPB Financial Well Being Questionnaire SF) is a five item scale measuring individual financial well-being. The CFPB Financial Well Being Questionnaire has a range of 0-20 raw score, based on a 5-point Likert scale for each item, with one item (item 4) reverse coded and summed with responses for the remaining items to arrive at the raw score. The raw score is converted to a reference financial well-being score.Higher scores indicate greater financial well-being.
- Child sleep [ Time Frame: Child age 15-months ]Child total minutes of sleep in 24-hour period
- Parental feeding styles [ Time Frame: 15-months ]Study investigators will assess responsive, pressuring and indulgent feeding styles using the "responsive satiety," "pressuring finishing," "pressuring soothing," and "indulgence permissive" sub-scales of the Infant Feeding Styles Questionnaire. These sub-scales assess both behaviors and beliefs relevant to the construct. Scores range from 1-5 with higher scores indicating greater use of that feeding style.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438721
|Contact: Amy L Beck, MD MPH||(415) firstname.lastname@example.org|
|United States, California|
|Children's Health Center at San Francisco General Hospital||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Amy L Beck, MD MPH|