HH/HF in 2-1-1 Systems
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StatusNot yet recruiting
Sponsors
Emory University
Collaborators
Centers for Disease Control and Prevention
CLINICAL TRIAL: NCT04373434
BioSeek: nct04373434
Keywords
Abstract
The hybrid-implementation effectiveness trial will evaluate a healthy eating and weight gain prevention intervention for delivery through 2-1-1s.
Description
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 hybrid-implementation effectiveness trial will evaluate a healthy eating and weight gain prevention intervention for delivery through 2-1-1s.
Dates
| Last Verified: | 04/30/2020 |
| First Submitted: | 04/28/2020 |
| Estimated Enrollment Submitted: | 04/30/2020 |
| First Posted: | 05/03/2020 |
| Last Update Submitted: | 04/30/2020 |
| Last Update Posted: | 05/03/2020 |
| Actual Study Start Date: | 05/31/2020 |
| Estimated Primary Completion Date: | 03/31/2022 |
| Estimated Study Completion Date: | 03/31/2022 |
Condition or disease
Weight Change, Body
Intervention/treatment
Behavioral: HH/HF in 2-1-1
Behavioral: Control
Phase
-
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: HH/HF in 2-1-1 The intervention will be delivered weekly alternating between phone and text/e-mail contact. The Coach will contact participants one week after baseline to review the home environment profile and select the first healthy action. The Coach will review the profile, then present a list of low-cost "healthy actions" that target possible environmental changes to make in the home. Using a series of open-ended questions, the coach guides participants to select a healthy action to work on. This will be followed at weekly intervals by text/e-mail check-ins to reinforce progress. More healthy actions are added in future calls, for a total of three healthy actions across three months. Participants will document the selected healthy actions on a family contract. The coaching calls, text messages and intervention materials are designed to increase behavioral capability, self-efficacy and behavioral intention to improve the home food environment for healthy eating and weight gain prevention. | Behavioral: HH/HF in 2-1-1 Coaching calls, text messages and intervention materials are designed to increase behavioral capability, self-efficacy and behavioral intention to improve the home food environment for healthy eating and weight gain prevention. Interviews will be conducted by trained research staff at baseline, one month post intervention and six months post intervention. Data collectors will implement proper probing techniques to ensure all foods, drinks, supplements, and home-made food item ingredients are included. |
| Active Comparator: Control Participants in the control condition will receive two mailings on healthy eating. They will be sent to participants one and six-weeks post-baseline. These materials focus on the same dietary outcomes as HH/HF in 2-1-1, but without the home environment emphasis. Participants will be sent their home environment profile with a list of healthy actions upon completion of the study. | Behavioral: Control The control intervention will focus on the same dietary outcomes as HH/HF in 2-1-1, but without the home environment emphasis. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - 18 to 70 years of age - able to speak English - and self-report BMI of 20 and above Exclusion Criteria: - pregnant women |
Outcome
Primary Outcome Measures
1. Change in USDA Healthy Eating Index (HEI) [Baseline and one-month and six-months follow up]
USDA Healthy Eating Index (HEI) is calculated from two telephone administered 24-hr dietary recalls (one weekday, one weekend day), which will be administered at to estimate total energy intake. The HEI uses a scoring system to evaluate a set of foods. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans and made up of 13 components.
Secondary Outcome Measures
1. Change in Kcal per day intake [Baseline and one-month and six-months follow up]
Kcal per day will be calculated and recorded. The most recent version of 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.
2. Change in self-reported weight [Baseline and one-month and six-months follow up]
Weight scale will be used by participants to measure weight and self report to the study coach at each time point
3. Changes to food environment [Baseline and one-month and six-months follow up]
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 TV on, use of non-home food sources for family meals, and frequency of shopping for fruits and vegetables.
