EatWell: Optimizing an mHealth Intervention to Change Food Purchasing Behaviors for Cancer Prevention

Sponsor
Drexel University (Other)
Overall Status
Completed
CT.gov ID
NCT04947150
Collaborator
National Cancer Institute (NCI) (NIH)
74
1
4
9.9
7.5

Study Details

Study Description

Brief Summary

Dietary intake is a powerful, modifiable factor that influences cancer risk. Unfortunately, most adults in the U.S. find it difficult to adhere to dietary guidelines for cancer prevention. One promising pathway for improving dietary adherence is to target grocery shopping habits, i.e., foods purchased for consumption at home. Two-thirds of daily food intake is sourced from or eaten in the home, so improving the quality of the home food environment should improve overall diet quality. When healthy foods are purchased and unhealthy foods are not, minimal self-control is needed to make healthy eating choices in the home. At the point of purchase, it is difficult to resist the temptation of palatable foods, but interventions might facilitate healthy choices by promoting dietary goal salience in real-time while grocery shopping, enhancing motivation to make and sustain changes to the diet, and increasing household support and accountability for healthy food purchasing. The proposed study will enroll adults who have low adherence to cancer prevention dietary recommendations. All participants will attend a nutrition education workshop conducted via Zoom. For 20 weeks, all participants also will receive once weekly reminders and recommendations for food purchasing via an app. The study will experimentally test four additional intervention components: location-triggered messages, coaching monitoring of food purchases, benefit of change content, and household member involvement. The preliminary aim of the study is to assess feasibility and acceptability of the intervention components. The primary aim of the study is to quantify the effect of each intervention component, individually and in combination, on dietary intake (assessed with 24-hour food recalls). The overarching goal of this project is to optimize this mHealth intervention, which can be tested in the future in a fully powered clinical trial.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Location-triggered notification
  • Behavioral: Reflections on benefits of change
  • Behavioral: Coach monitoring
  • Behavioral: Household support
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
This is a 2x2x2x2 design. There are four factors, each with two levels: ON vs OFF.This is a 2x2x2x2 design. There are four factors, each with two levels: ON vs OFF.
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcomes assessors will be blind to condition.
Primary Purpose:
Prevention
Official Title:
Optimizing an mHealth Intervention to Change Food Purchasing Behaviors for Cancer Prevention
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
Mar 29, 2022
Actual Study Completion Date :
Mar 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LOCATION TRIGGERED MESSAGING

Weekly message is triggered when arriving at grocery store.

Behavioral: Location-triggered notification
If participants are randomized to have this component ON, the app will send the notification when the participant's smartphone is within a 50-meter "geofence" around designated grocery stores. No more than one notification will be sent per week. Mindfulness of program goals in the moment of decision making is expected to facilitate program-consistent food purchasing behaviors. Participants assigned to have location-triggered message delivery OFF will receive their weekly "recommendations and reminders" messages at standard times throughout the week. The content of the messages will not differ according to whether this component is ON vs. OFF.

Experimental: COACH MONITORING

Coaches view grocery purchases via web portal, send weekly messages about purchases they observe, and conduct three brief phone calls to discuss purchases.

Behavioral: Coach monitoring
Coaches will monitor participant food purchases via a dashboard for viewing purchase data, and send messages designed to provide feedback and enhance supportive accountability for program goals. The messages will provide reinforcement for purchases consistent with program goals and express concern for areas in which adherence is low. Participants assigned to have this component OFF will not receive these extra messages or phone calls, and their food purchases will only be viewed by research staff for research outcome assessment purposes.

Experimental: BENEFITS OF CHANGE

Attend an extra workshop session and three phone calls to identify and reflect on benefits of dietary change. Content added to standard weekly messages about benefits of change.

Behavioral: Reflections on benefits of change
Participants will reflect on anticipated benefits of purchasing healthy foods, consistent with motivational interviewing and self-determination theory. Message content will be personalized as follows: During the initial workshop, all participants will complete an exercise identifying benefits of healthy eating that are important to them. Message content will then be programmed to be personalized according to anticipated rewards important to that participant. Participants assigned to have this intervention component OFF will not have content about anticipated benefits of change added to any messages.

Experimental: HOUSEHOLD SUPPORT

An adult household member attends one workshop session and three phone calls with the index participant. This household member receives weekly text messages for 20 weeks about program goals and ways to support the index participant.

Behavioral: Household support
If participants are assigned to have household support ON, one adult in the household will receive weekly text messages designed to elicit support for changing food purchases. In addition, the index participant and household member will be invited to participate in one extra workshop session and three brief coaching calls focused on household support. If participants are assigned to have this OFF, household members will have no program involvement.

Outcome Measures

Primary Outcome Measures

  1. Dietary intake [Baseline and post-treatment (0 and 20 weeks)]

    In Wave 1, the primary outcome will be change from 0-20 weeks in dietary intake of the major food categories from the American Institute for Cancer Research guidelines. Self-reported dietary recalls will be completed for three days at baseline and week 20 using the Automated Self Administered 24-hour food recall (ASA-24).

  2. Dietary intake [Baseline and post-treatment (0 and 20 weeks)]

    In Wave 2, the Diet History Questionnaire (DHQ-III) will be used instead of food recalls to assess dietary intake.

Secondary Outcome Measures

  1. Goal salience [0, 10, 20 weeks]

    Goal salience measure (self-report) created specifically for the purposes of this study

  2. Supportive Accountability [0, 10, 20 weeks]

    Items adapted from the Supportive Accountability Measure

  3. Motivation [0, 10, 20 weeks]

    Items adapted from the Treatment Self-Regulation Questionnaire

  4. Social support [0, 10, 20 weeks]

    Items adapted from the Sallis Social Support for Diet

  5. Quality of household relationship [0 weeks]

    Items adapted from the Relationship Assessment Scale

  6. Demographics, household, and grocery information [0 weeks]

    Demographics, household, and grocery information

  7. Weight History [0 weeks]

    Weight History Questionnaire created specifically for the purposes of this study

  8. Restraint, uncontrolled eating, disinhibited eating [0, 10, 20 weeks]

    Three Factor Eating Questionnaire - 21 item version

  9. Dietary intake [0, 10, 20 weeks]

    Items adapted from the Food Frequency Questionnaire

  10. Treatment Acceptability [10, 20 weeks]

    Items adapted from the Treatment Acceptability Questionnaire

  11. Qualitative feedback [20 weeks]

    Focus group

  12. Goals and stages of change- household member [0 weeks]

    Household Goals Questionnaire created specifically for the purposes of this study, completed by the selected household member

  13. Dietary intake-household member [0, 20 weeks]

    Items adapted from the Food frequency questionnaire, completed by the selected household member

  14. Treatment Acceptability - household [20 weeks]

    Items adapted from the Treatment Acceptability Questionnaire, completed by the selected household member

Other Outcome Measures

  1. Adherence to AICR cancer prevention guidelines [Baseline and post-treatment (0 and 20 weeks)]

    Categorical change in adherence to each of the AICR guidelines will be assessed from 0-20 weeks using the ASA-24.

  2. Grocery store purchases [Baseline and post-treatment (0 and 20 weeks)]

    Change in purchases of items will be collected via grocery store loyalty programs

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion criteria

  • 18 years or older

  • Fluent in English

  • Low adherence to cancer prevention dietary guidelines, operationalized as a score of ≤ 2 out of 4 using the National Cancer Institute method for assessing adherence to World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) lifestyle recommendations. This three-level scoring system (meeting/partially meeting/not meeting each recommendation) includes 4 items specific to diet. Participants must score equal or less than 2, meaning that they are fully meeting recommendations for no more than 2 of the 4 dietary recommendations.

  • Performs the majority of the household's food shopping, and do so at stores that can passively stream item-level data from a store loyalty card to the Information Machine API (e.g., Walmart, Target, ShopRite, Wegman's, etc.)

  • Has a smartphone with iOS or Android operating system that is compatible with the program app

  • Lives in a household with at least one other adult who consents to being randomized to possibly receive messages on his/her own cell phone through the program app

Exclusion criteria

  • Medical condition or psychiatric condition (e.g., active substance abuse, eating disorder) that may limit appropriateness of or ability to comply with program dietary recommendations

  • Planning to enroll in another lifestyle modification program in the next 6 months

  • Bariatric surgery history

  • Currently pregnant or breastfeeding or planning to become pregnant in the next 6 months

Contacts and Locations

Locations

Site City State Country Postal Code
1 Drexel University Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Drexel University
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Meghan L Butryn, PhD, Drexel University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Meghan Butryn, Associate Professor of Psychology, Drexel University
ClinicalTrials.gov Identifier:
NCT04947150
Other Study ID Numbers:
  • 1R21CA252933
  • 1R21CA252933
First Posted:
Jul 1, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 30, 2022