Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Rare Diseases

Obesity

Body Weight

Body Weight Changes

Weight Gain

Chronic Graft Versus Host Disease

Participants randomized to the HH/HF study intervention will work with a coach through phone calls and text messages for 12 weeks to set goals targeting home-based environmental determinants of dietary behaviors.

Participants in the control condition will receive two mailings which focus on the same dietary outcomes as the HH/HF intervention but without the home environment emphasis.

The HH/HF Intervention involves coaching calls, text messages and intervention materials that are designed to increase behavioral capability, self-efficacy and behavioral intention to improve the home food environment for healthy eating and weight gain prevention. The intervention is delivered over a 12 week period.

Health Homes/Healthy Families (HH/HF) Intervention

Participants in the control condition will receive two mailings on healthy eating, the first from the "Dietary Guidelines For Americans 2015-2020, 8th Edition" and the second from "Choose MyPlate". Additionally, both mailings will include a food diary from the Centers for Disease Control and Prevention. Mailings will be sent to participants one and six-weeks post-baseline. These materials focus on the same dietary outcomes being targeted in the HH/HF intervention, but without the home environment emphasis. Control group participants will receive their home environment profile with a list of healthy actions upon completion of the study.

Control

Michelle Kegler, DrPH/MPH

This trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number.

It is now well-established that obesity and excess weight increase the risk of cancer (i.e., colorectal and post-menopausal breast cancer), as well as other chronic diseases including diabetes, stroke, coronary heart disease, and arthritis. The World Cancer Research Fund and the American Institute for Cancer Research state "maintenance of a healthy weight throughout life may be one of the most important ways to protect against cancer". Unfortunately, adults generally gain weight as they age.

Healthy Homes/Healthy Families (HH/HF) Intervention involves a tailored home environment profile and a health coach working with participants to select and implement a series of healthy actions to create a home environment more supportive of healthy eating and physical activity.

The Federal Communications Commission (FCC) designated 2-1-1 as the 3-digit number to call for information and referrals to social services and other assistance in the United States. This study will evaluate a healthy eating and weight gain prevention intervention for delivery through 2-1-1 calls.

Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers

A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention Among 2-1-1 Callers

Individual participant data that underlie the results, after de-identification will be shared

The USDA HEI measures diet quality and is calculated from two telephone administered 24-hr dietary recalls (one weekday, one weekend day). The HEI evaluates foods with a scoring system using 13 components for different food groups and the key recommendations of the 2015-2020 "Dietary Guidelines for Americans". Scores range from 0 to 100 where a score of 100 is an ideal score indicating that a diet follows the key recommendations of the 2015-2020 "Dietary Guidelines for Americans".

Kcal per day will be calculated and recorded. The most recent version of the Automated Self-Administered 24-hour dietary recall (ASA24) program prompts for food description details and automatically codes and calculates nutrient intakes using the USDA Food and Nutrient Database for Dietary Studies. The average of one weekday and one weekend day will be used to estimate Kcal per day at each time point.

Participants will self-report weight in pounds each time point

A home environment survey will be administered via telephone at each time point to assess household food inventory, food preparation methods, meals/snacks with the television on, use of non-home food sources for family meals, and frequency of shopping for fruits and vegetables.

Centers for Disease Control and Prevention

Emory University

Professor

Heart and Blood Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Heart Failure

Kidney Diseases

Diabetes Mellitus

Kidney Failure, Chronic

Hepatic Insufficiency

Liver Failure

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Insufficiency, Chronic

Chronic Disease

Disease Attributes

Liver Diseases

Gastrointestinal Diseases

Receive meal delivery for 2 weeks (1 meal per day for a total of 14 days). The medically tailored meal ordered for each participant will depend on their medical conditions.

Receive meal delivery for 4 weeks (1 meal per day for a total of 28 days). The medically tailored meal ordered for each participant will depend on their medical conditions.

Medically Tailored Meals

Rebecca S Boxer, MD, MS

John Steiner, MD, MPH

The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Medically tailored meals (MTM) are meals that are approved by a dietitian and shown to help people with certain health conditions.

The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Medically tailored meals (MTM) are meals that are approved by a dietitian and shown to help people with certain health conditions.

The Investigators propose a research study with four Specific Aims:

Specific Aim 1: To determine if MTM provided post hospitalization for 4 weeks to patients with one or more of seven chronic health conditions will decrease depression/anxiety measured by the Hospital Anxiety and Depression Scale (HADS) at 60 days in comparison to meals provided for 2 weeks to members discharged from two hospitals.

Hypothesis 1: Patients receiving meals for 4 weeks will have a clinically significant increase in their HADS score at 60 days compared to those receiving meals for 2 weeks.

Specific Aim 2: To determine if MTM provided for 4 weeks to patients with one or more of seven chronic health conditions post hospitalization will improve general well-being and functional status measured by Katz's Activities of Daily Living (ADL).

Hypothesis 2: Patients receiving meals for 4 weeks will have a clinically significant increase in their sense of well-being and ADLs at 60 days compared to those receiving meals for 2 weeks.

Specific Aim 3: To determine if MTM provided for 4 weeks to patients with one or more of seven chronic health conditions post hospitalization will decrease a composite outcome of rehospitalizations and emergency department (ED) visits at 60 days in comparison to: a) meals provided for 2 weeks to members discharged from two hospitals; and b) a concurrent prospective control group not receiving meals at two other KPCO-contracted hospitals.

Hypothesis 3: Patients receiving meals for 4 weeks will have a decreased composite rate of rehospitalizations and ED visits at 60 days compared to those receiving meals for 2 weeks or the non-randomized control group.

Specific Aim 4: To determine the feasibility, acceptability and scalability of the Meals Matter Program to KP members, their households, and hospital leadership and staff.

This is a randomized trial to compare two approaches to meal delivery. Group 1 will receive meal delivery for 2 weeks (1 meal per day for a total of 14 days) and Group 2 will receive meal delivery for 4 weeks (1 meal per day for a total of 28 days). A concurrent propensity matched control group which will not receive an intervention will also be used.

Meals MATTER: A Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge

Meals MATTER: A Randomized Controlled Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge

Measured through the Hospital Anxiety and Depression Scale. 0 = Minimum. 21 = Maximum. Higher score is worse outcome.

Measured through the Katz Activities of Daily Living. Minimum = 0, Maximum = 6. Higher score is better outcome.

Measured through time of discharge through re-hospitalization or Emergency Department visit

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers	NCT04373434	Weight Change, ...	Health Homes/He... Control	18 Years - 70 Years	Emory University
Meals MATTER: A Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge	NCT04351880	Heart Failure Copd Liver Failure Diabetes Mellit... Cancer End Stage Renal...	Medically Tailo...	18 Years -	Kaiser Permanente
Meals MATTER: A Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge	NCT04351880	Heart Failure Copd Liver Failure Diabetes Mellit... Cancer End Stage Renal...	Medically Tailo...	18 Years -	Kaiser Permanente
Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers	NCT04373434	Weight Change, ...	Health Homes/He... Control	18 Years - 70 Years	Emory University

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