Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
NCT ID:
NCT05309395
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT05309395
Study Brief:
Protocol Section:
NCT05309395