Overweight and Obesity
Conditions
Keywords
obesity, overweight, produce prescription, produce voucher, nutrition, nutrition security
Brief summary
The goal of this study is to understand the best practices for implementing produce prescriptions among adults with overweight or obesity experiencing nutrition insecurity. Enrolled participants will receive an 8-week intervention aimed at increasing nutrition knowledge, self-efficacy for healthy eating, and barriers to healthy food access. Participants will be randomly assigned to one of two produce prescription implementation strategies: Program 1: Participants will receive weekly produce vouchers that are redeemable at a local vendor. Program 2. Participants will receive fresh produce delivered directly to the participant's home. These boxes will be tailored based on household size, cooking and preparation preferences, and produce the participant prefers to receive. Researchers will compare engagement in and adherence to the intervention and the patterns of difference in 8-week changes in fruit and vegetable consumption and weight.
Interventions
BEHAVIORALBehavioral Text Messages and Produce Box Delivery
Participants will receive a produce box delivered weekly to the participants home customized based on the participants cooking preferences and household size. Participants will also receive a daily text message aimed to support a healthy diet and lifestyle. These texts will include information to build participants' knowledge and skills for healthy eating. The participants will also include weekly goals that focus on eating a healthy diet. Participants will receive automated, personalized feedback via text messages based on participant goal attainment and daily responses.
BEHAVIORALBehavioral Text Message Program and Produce Voucher
Participants will receive a weekly produce voucher redeemable at a local market vendor for fresh produce of the participant's choice. Participants will also receive a daily text message aimed to support a healthy diet and lifestyle. These texts will include information to build participants' knowledge and skills for healthy eating. The participants will also include weekly goals that focus on eating a healthy diet. Participants will receive automated, personalized feedback via text messages based on goal attainment and daily responses.
Sponsors
Johns Hopkins University
Maryland Department of Health and Mental Hygiene
Maryland Cigarette Restitution Fund
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult 18 years of age or older * Living with overweight or obesity, defined as a BMI ≥25 * Screens positive for nutrition insecurity * Has a smartphone with a data plan * Willing to receive daily text messages * Has an address that can receive delivery * Can read and write in English * Is willing to pick up produce at the Northeast Market
Exclusion criteria
* Participating in another related research study * Currently taking weight loss drugs * Cardiovascular disease event in the last 6 months * Active cancer * Recent hospitalization due to psychiatric condition or event * Pregnancy or planned during the study period * Currently breastfeeding * Documented dementia * On kidney dialysis * Planned or recent bariatric surgery * Weight exceeding 440 lbs. * Exclusion at principal investigators discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reached | From screening up to 8 weeks | The investigators will track the number of number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutrition Insecurity as Assessed by the 4-item Nutrition Security Screening Questionnaire | Baseline to 8 weeks | Nutrition insecurity will be assessed using Center for Nutrition Health and Impact questionnaire with a 4-item scale. The higher the score, the greater the level of food security and control an individual has over their nutrition. The four items within the measure are scored from 0 to 4. Then, the measure's score is simply the mean of the responses. |
| Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT) | Baseline, 4 weeks, and 8 weeks | Consumption of food groups will be assessed using the 9-item Mini-Eating Assessment Tool (EAT) questionnaire. Evaluates consumption of key food groups. Fruit and vegetable consumption were each based on two questions within the MINI eat scale, not subscales. Fruit ranges from 1 to 7 where 1 = less than 1 serving per week, and 7 = 4 or more servings per day. Vegetables range from 1 to 6 where 1 = less than 3 servings per week, and 6 = 4 or more servings per day. Mini-EAT score range 0-90. Higher scores better consumption. |
| Weight (kg) | Baseline, 8 weeks | Weight will be taken by study staff and measured to the nearest 0.1 kg. |
| Blood Pressure (mmHg) | Baseline, 8 Weeks | Blood pressure was measured using the Omron 10 Series ® Upper Arm Blood Pressure Monitor. Participants were instructed to rest for five minutes before two blood pressure readings were taken on the upper arm, one minute apart. Measurements were averaged for analysis. |
| Health Self-Efficacy as Assessed by the 11-item Healthy Eating and Weight Self-Efficacy Scale | Baseline, 8 weeks | Self-efficacy was measured using the 11-item Healthy Eating and Weight Self-Efficacy Scale. Responses were rated on a Likert scale that ranged from "Strongly Disagree" to "Strongly Agree". Responses were summed to create a total score ranging from 11 to 55, with higher scores representing greater self-efficacy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHailey Miller Assistant Professor, RN, PhD
Johns Hopkins University
Participant flow
Recruitment details
The recruitment and screening processes will be conducted at the Northeast Market. During interactions with community members, the research team will inform individuals of the current study and if interested, help them complete initial screening forms. If the individual remains eligible and interested, a nurse will complete the screening, including measuring height and weight, in a semi-private space at the market.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50 Years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 25 |
| other Total, other adverse events | 0 / 23 | 0 / 25 |
| serious Total, serious adverse events | 0 / 23 | 1 / 25 |
Outcome results
None listed