Dataset Information

Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial.

ABSTRACT:

Background

Food insecurity is associated with worse glycemic management for individuals with type 2 diabetes mellitus (T2DM), but whether medically tailored meals (MTM), a food insecurity intervention, can improve glycemic management is unclear.

Objective

To describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, relative to a food subsidy (money that can be spent on foods participants choose), for adults with both T2DM and food insecurity.

Methods

The Food as Medicine for Diabetes (FAME-D) randomized clinical trial (goal n = 200) is a pragmatic trial with an active comparator. Participants, who will have T2DM and report food insecurity, will be randomly assigned to a 6-month MTM plus telephone-delivered lifestyle change intervention, or a 6-month food subsidy ($40/month). The primary outcome is HbA1c at 6 months. Secondary outcomes include HbA1c at 12 months to assess whether the intervention effect (if any) is sustained, along with weight, food insecurity, diabetes distress, and health-related quality of life. Qualitative analyses of semi-structured interviews will help understand why, how, and under what circumstances the intervention achieved its observed results.

Conclusion

Results from FAME-D will help inform clinical management of food insecurity when it co-occurs with T2DM. Further, results may be useful as healthcare payors are considering coverage for MTM interventions.

Clinicaltrials

gov: NCT04828785.

SUBMITTER: Berkowitz SA

PROVIDER: S-EPMC9839527 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial.

Berkowitz Seth A SA Kruse Gina R GR Ball Ricks Katharine A KA Burch Jessica J Ouimet Ethan E Kitzis Beth B Forrest Colleen C Terranova Jean J Stewart Paul W PW Buse John B JB Keyserling Thomas C TC Wexler Deborah J DJ Delahanty Linda M LM

Contemporary clinical trials 20221205

<h4>Background</h4>Food insecurity is associated with worse glycemic management for individuals with type 2 diabetes mellitus (T2DM), but whether medically tailored meals (MTM), a food insecurity intervention, can improve glycemic management is unclear.<h4>Objective</h4>To describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, relative to a food subsidy (money that can be spent on foods participant ...[more]

PMID: 36470556

Similar Datasets

Project description:BackgroundFood insecurity, defined as inconsistent food access owing to cost, leads to poor health.ObjectiveTo test whether a medically tailored meal delivery program improved dietary quality in individuals with type 2 diabetes and food insecurity.DesignRandomized cross-over clinical trial.ParticipantsForty-four adults with diabetes, hemoglobin A1c > 8.0%, and food insecurity (defined as at least one positive item on the two-item "Hunger Vital Sign").InterventionIn the Community Servings: Food as Medicine for Diabetes cross-over clinical trial (NCT02426138), conducted from June 2015 to July 2017, we randomly assigned the order of "on-meals" (home delivery of 10 meals/week for 12 weeks delivered by Community Servings, a non-profit organization) and "off-meals" (12 weeks usual care and a Choose MyPlate healthy eating brochure) periods.Main measuresThe primary outcome was Healthy Eating Index 2010 score (HEI), assessed by three 24-h food recalls in both periods. Higher HEI score (range 0-100; clinically significant difference 5) represents better dietary quality. Secondary outcomes included food insecurity and self-reported hypoglycemia.Key resultsMean "on-meal" HEI score was 71.3 (SD 7.5) while mean "off-meal" HEI score was 39.9 (SD 7.8) (difference 31.4 points, p < 0.0001). Participants experienced improvements in almost all sub-categories of HEI score, with increased consumption of vegetables, fruits, and whole grains and decreased solid fats, alcohol, and added sugar consumption. Participants also reported lower food insecurity (42% "on-meal" vs. 62% "off-meal," p = 0.047), less hypoglycemia (47% "on-meal" vs. 64% "off-meal," p = 0.03), and fewer days where mental health interfered with quality of life (5.65 vs. 9.59 days out of 30, p = 0.03).ConclusionsFor food-insecure individuals with diabetes, medically tailored meals improved dietary quality and food insecurity and reduced hypoglycemia. Longer-term studies should evaluate effects on diabetes control (e.g., hemoglobin A1c) and patient-reported outcomes (e.g., well-being).

Project description:BackgroundInability to adhere to nutritional recommendations is common and linked to worse outcomes in patients with nutrition-sensitive conditions.ObjectivesThe purpose of this study is to evaluate whether medically tailored meals (MTMs) improve outcomes in recently discharged adults with nutrition-sensitive conditions compared with usual care.Research designRemote pragmatic randomized trial.SubjectsAdults with heart failure, diabetes, or chronic kidney disease being discharged home between April 27, 2020, and June 9, 2021, from 5 hospitals within an integrated health care delivery system.MeasuresParticipants were prerandomized to 10 weeks of MTMs (with or without virtual nutritional counseling) compared with usual care. The primary outcome was all-cause hospitalization within 90 days after discharge. Exploratory outcomes included all-cause and cause-specific health care utilization and all-cause death within 90 days after discharge.ResultsA total of 1977 participants (MTMs: n=993, with 497 assigned to also receive virtual nutritional counseling; usual care: n=984) were enrolled. Compared with usual care, MTMs did not reduce all-cause hospitalization at 90 days after discharge [adjusted hazard ratio, aHR: 1.02, 95% confidence interval (CI), 0.86-1.21]. In exploratory analyses, MTMs were associated with lower mortality (aHR: 0.65, 95% CI, 0.43-0.98) and fewer hospitalizations for heart failure (aHR: 0.53, 95% CI, 0.33-0.88), but not for any emergency department visits (aHR: 0.95, 95% CI, 0.78-1.15) or diabetes-related hospitalizations (aHR: 0.75, 95% CI, 0.31-1.82). No additional benefit was observed with virtual nutritional counseling.ConclusionsProvision of MTMs after discharge did not reduce risk of all-cause hospitalization in adults with nutrition-sensitive conditions. Additional large-scale randomized controlled trials are needed to definitively determine the impact of MTMs on survival and cause-specific health care utilization in at-risk individuals.

Dataset Information

Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial.

Background

Objective

Methods

Conclusion

Clinicaltrials

Publications

Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial.

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