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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-24
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Grocery intervention - unrestricted

    Behavioral

    Receives financial support in an unrestricted fashion (i.e., can use the money for whatever they need).

  • Grocery intervention - restricted

    Behavioral

    Receives financial support restricted to the purchase of items at a grocery store, and with monthly grocery shopping coaching from a trained nutrition expert.

Treatment groups

228 Participants
are divided into 2 treatment groups
Group A: Cash Benefit GroupActive comparator 1 intervention
Group B: Grocery Benefit GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in BMI (Body Mass Index)

At 12 months post-enrollment (24 months of age).

Time frame
1 year

Secondary outcomes

Other outcomes

1

Change in Food Security

As measured by an 18 item food insecurity screen to assess food insecurity levels.

Time frame
baseline, 3, 6, 9 and 12 months
2

Change in Infant Dietary Quality

As measured by the USDA multipass food recall tool (ASA24).

Time frame
baseline, 6 months, and 12 months
3

Change in Unmet social needs

Changes in social determinants of health affecting the family as measured by the HealthLeads questionnaire.

Time frame
baseline, 6 months, and 12 months
4

Perceived stress scale

As measured by a 10 item perceived stress scale for parents.

Time frame
baseline, 6 months, and 12 months

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