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Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health

Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health: A Multi-disciplinary Approach for Study and Mitigation of Food Insecurity and Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Months to 24 Months
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Both will provide families with $50/week for one year of study enrollment."
  • "Patients will have the opportunity to participate in post-study interviews to report on intervention satisfaction, and facilitators and barriers of infant feeding."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether helping families get enough food can improve young children's BMI, a measure of weight compared with height, over one year. It is for babies ages 9–12 months with a high BMI or weight whose families may have trouble getting enough food. Families will receive either $50 a week in cash or $50 a week in groceries, with help from a nutrition expert, for one year.

Food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. While existing research shows that food benefit programs reduce food insecurity, little is known about the mediating factors between food benefit programs and child health. The purpose of this study is to understand if the resolution of food insecurity in young children with early onset obesity can improve body mass index (BMI) over one year, and if so, by what mechanisms. The investigators will conduct a randomized comparative effectiveness study among infants (n=228) aged 12 months at risk for food insecurity and deliver two different food security interventions. Both will provide families with $50/week for one year of study enrollment. The first group will receive this as an unrestricted cash benefit ("cash benefit group") and the second group will receive this as a benefit in the form of weekly grocery purchases with the support of a trained nutrition expert to guide healthy grocery purchasing ("grocery benefit group"). The investigators will also construct a contemporary comparison cohort of infants meeting the inclusion/exclusion criteria from the electronic health record, using propensity score matching to allow comparisons between both intervention groups and usual care. The primary endpoint is difference in BMI at 12 months post-enrollment (24 months of age). Secondary outcomes include measures of nutrition, food security, electronic health record data related to general child health, and other factors related to parental stress and unmet social needs. Patients will have the opportunity to participate in post-study interviews to report on intervention satisfaction, and facilitators and barriers of infant feeding. Data analysis will be conducted by a trained statistician (Duke Biostatistics, Epidemiology, and Research Design; BERD) and will employ a two-means test for a repeated-measures design. The benefits to participants outweigh the minimal risks of loss of privacy, and confidential information will be managed carefully to minimize this risk.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Baby is 9–12 months old and joins with their main caregiver.
  • Family qualifies for Medicaid and WIC, a food support program.
  • Baby's BMI is at or above the 85th percentile on the World Health Organization growth chart, or the baby weighs at least 20 pounds at 9 months old.
  • Caregiver's main language is English or Spanish.
  • Baby was not born as a twin or part of another multiple birth.

Who can't join

  • Baby has obesity caused by a change in a single gene.
  • Family plans to move out of the area within the next 12 months.
  • Parent is currently pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion: * Aged 9-12 months and their primary caregiver "parent". * Medicaid and WIC-eligible (proxy for "at risk for food insecurity") * World Health Organization BMI ≥ 85%ile at current or most recent encounter (early-onset obesity) OR ≥ 20 pounds at 9 months old. * Caregiver speaks either English or Spanish as their primary language. * Infant was born as a singleton infant. Exclusion: * Diagnosed with monogenic obesity. * Plans to move from the area in the next 12 months. * Parent is currently pregnant.

Study sites (1)

NC