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Completed

NCT Number: NCT05586269

Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity

The goals of this study are to 1) pilot the feasibility of a novel meal kit delivery intervention in families and children with food insecurity and obesity and 2) evaluate the implementation of the pilot intervention.

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Key information

Conditions

Pediatric Obesity Body Weight Child Nutrition Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overnutrition, Child Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

Childhood obesity prevalence is rising in the U.S. and is known to track into adulthood, increasing the risks of chronic diseases such as type 2 diabetes. Households of children with obesity also face unmet social needs, such as food insecurity. Food insecurity is associated with poorer dietary quality and higher prevalence of obesity and diabetes in adults; however, data are inconsistent and less known regarding longitudinal health effects in children. Because food insecurity and childhood obesity tend to co-occur in Black, Hispanic, and lower-income households, there is an urgent need to examine and intervene in the social determinants associated with rising childhood obesity prevalence.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Child Inclusion Criteria:

  • Children >=6 years and <12 years old with a BMI >=95th percentile
  • Children who screen positive on the 2-item Hunger Vital Sign™
  • Children living in a household of <=5 people
  • Children living with an English and/or Spanish-speaking caregiver
  • Children living within the EatWell delivery map boundaries in the greater Boston area

Child Exclusion Criteria:

  • History of food allergies or intolerance to dairy, gluten, soy, or any potential component of the meal kit
  • History of malabsorptive intestinal disease (e.g., Crohn's disease, celiac disease)
  • History of type 1 or 2 diabetes
  • History of solid tumor or bone marrow transplant
  • Enteral tube dependence

The child's primary caregiver will be eligible for enrollment.

Treatment and study plan

Meal Kit Delivery

Behavioral

Dyads (caregiver + child) receive one meal kit delivery per week. One meal kit is designed to include two recipes and ingredients to prepare 10 servings (~2 meals for a household 5 people). Meal kits come with printed picture-based recipes in English or Spanish and access to online cooking demonstrations.

Other names: EatWell Meal Kits

Newsletter + Food Pantry Referral

Behavioral

Dyads (caregiver + child) receive a printed newsletter in English and Spanish that lists additional local food assistance resources. Dyads receive a referral to the clinic's associated food pantry.

Other names: Standard of Care

Primary outcomes

  1. Study Feasibility: Recruitment

    Time frame: 2 months to baseline

    Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.

  2. Study Feasibility: Randomization

    Time frame: At baseline

    Number of participants enrolled per month, then subject to randomization.

  3. Study Feasibility: Retention

    Time frame: At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16).

    Number of participants retained at each study visit

  4. Study Feasibility: Protocol

    Time frame: Third study visit (week 14-16)

    Number of participants who reported receipt of all six weeks of meal kit delivery

  5. Study Feasibility: Adherence - Caregivers

    Time frame: Third study visit (week 14-16)

    Total number of recipes prepared by caregivers

  6. Study Feasibility: Adherence - Children

    Time frame: Third study visit (week 14-16)

    Number of children who tasted/ate food from the meal kit

  7. Study Feasibility: Assessments

    Time frame: At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)

    Proportion of planned assessments completed at each study visit

Secondary outcomes

  1. Number of Participants With Household Food Insecurity at the First Study Visit

    Time frame: At the baseline first study visit (baseline)

    Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into:

    Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security

  2. Number of Participants With Household Food Insecurity at Second Study Visit

    Time frame: At second study visit (week 6-8)

    Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into:

    Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security

  3. Number of Participants With Household Food Insecurity at Third Study Visit

    Time frame: At third study visit (week 14-16)

    Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into:

    Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security

  4. Change in BMI For Children With BMI Assessments At All Visits

    Time frame: At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)

    Weight and height were combined to report BMI in kg/m^2 based on Centers for Disease Control growth curves.

  5. Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits

    Time frame: At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)

    BMI percentage of the 95th percentile (BMIp95) was calculated using CDC extended BMI-for-age growth charts for children with BMI assessments at all study visits

Other outcomes

  1. Total Prime Diet Quality Score at Each Study Visit: Children

    Time frame: At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)

    The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the child (parent-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality.

  2. Total Prime Diet Quality Score at Each Study Visit: Caregiver

    Time frame: At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)

    The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the caregiver (self-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality.

  3. Caregiver Reported Mealtime Behavior at First Study Visit

    Time frame: At baseline first study visit (baseline)

    Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"

  4. Caregiver Reported Mealtime Behavior at Second Study Visit

    Time frame: At second study visit (week 6-8)

    Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"

  5. Caregiver Reported Mealtime Behavior at Third Study Visit

    Time frame: At third study visit (week 14-16)

    Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"

  6. Caregiver Perceived Stress at First Study Visit

    Time frame: At baseline first study visit (baseline)

    The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress:

    0-13: low stress 14-26: moderate stress 27-40: high perceived stress

  7. Caregiver Perceived Stress at Second Study Visit

    Time frame: At second study visit (week 6-8)

    The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress:

    0-13: low stress 14-26: moderate stress 27-40: high perceived stress

  8. Caregiver Perceived Stress at Third Study Visit

    Time frame: At third study visit (week 14-16)

    The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress:

    0-13: low stress 14-26: moderate stress 27-40: high perceived stress

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 19, 2022
Registry last updated
May 22, 2025

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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