Kaiser Permanente
Pasadena, California, 91101, United States
Location status: Recruiting
Location contact
Erika Estrada, MPH
CONTACT
Galina INzhakova, MPH
CONTACT
NCT Number: NCT05309395
This is an Randomized controlled trial (RCT) to assess the impact of meal planning and affordable grocery delivery on weight loss, dietary quality and health on members of multigenerational Latino households.
Interested in participating?
Request Info2 year and older
All sexes
Interventional
Phase 3
Pasadena, California, 91101, United States
Location status: Recruiting
Erika Estrada, MPH
CONTACT
Galina INzhakova, MPH
CONTACT
FoodRx will test the effects of a culturally sensitive meal planning and affordable grocery delivery service in a randomized controlled trial to improve diet quality, weight control and chronic disease risk among multi-generational Latino households. This will be the first study to test the effectiveness of food prescriptions and home delivery on BMI and diet quality among Latino families. Food prescriptions will meet the EAT-Lancet sustainability guidelines and achieve at least 90% of the recommended dietary allowances (RDAs) for 23 critical nutrients for all family members at a cost not exceeding $680/month, the current CalFresh [California's Supplemental Nutrition Assistance Program (SNAP)] budget allocated for a family of four. Investigators will include tailored directions on portion size based on age, sex, activity level and weight goals. Investigators will develop and validate our menus and test logistics with focus groups of Latino adults with overweight or obesity [Body mass index (BMI) >25 kg/m2]. Thereafter, 180 Latino households of 3-5 people (n=720) from Kaiser Permanente members with at least two individuals with overweight or obese and at least 1 child aged 5-10 years will participate in a 6-month randomized trial with a wait-list cross-over design. Based on the weekly menu plan, a grocery list will be generated, and items delivered to the home. Anthropometric measurements, blood pressure, and dietary intake and blood samples will be collected at baseline, 6, and 12 months. Each family will be expected to pay for the majority of grocery costs, with the amount above this covered as an incentive for participation. Specific aims are: 1. To develop an affordable and culturally sensitive meal-planning and grocery delivery intervention for Latino households. 2) To determine the impact of food prescriptions and grocery delivery on parental health and diet quality. 3) To determine the impact of food prescriptions and grocery delivery on child health and diet quality. In a cross-center aim, data from this Project will be combined with Projects 1 and 2 to examine 1) the multi-level determinants of chronic disease risk in Latino children and 2) the effects of different types of interventions and how social and environmental factors in Latino affect the response to intervention.
Measure include BMI for adults and BMI z-score (primary outcome) for children, dietary quality, cognitive function in children, blood pressure, HbA1C, blood lipids and liver function (ALT/AST) (secondary outcomes) and compare intervention with wait-list control participants. If the approach proves effective, food prescriptions could provide a scalable and sustainable model to improve the diet, health, and well-being of Latino families.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive weekly meal plans and recipes and the groceries required to prepare the recommended meals
Other names: Meal planning and grocery delivery
Time frame: through study completion, an average of 1 year
Changes in BMI
Time frame: through study completion, an average of 1 year
Participants will complete the ASA24-2020
Time frame: 6 months
biomarker of blood glucose
Time frame: 6 months
Liver function tests
Time frame: 6 months
level of cholesterol
Time frame: 6 months
Blood pressure
Contact information is provided by the study sponsor or research team.
Deborah A Cohen, MD, MPH
CONTACT
Galina Inzhakova
CONTACT
Kaiser Permanente
Other
Food Prescriptions to Promote Affordable Diets That Meet RDAs Among Multi-generational Latino Households
Acronym: FoodRx
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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