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

NCT ID: NCT04947150

Last Updated: 2023-10-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-03-29

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This is a 2x2x2x2 design. There are four factors, each with two levels: ON vs OFF.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessors will be blind to condition.

Study Groups

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LOCATION TRIGGERED MESSAGING

Weekly message is triggered when arriving at grocery store.

Group Type EXPERIMENTAL

Location-triggered notification

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Coach monitoring

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Reflections on benefits of change

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Household support

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Drexel University

OTHER

Sponsor Role lead

Responsible Party

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Meghan Butryn

Associate Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meghan L Butryn, PhD

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

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Drexel University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Butryn ML, Hagerman CJ, Crane NT, Ehmann MM, Forman EM, Milliron BJ, Simone NL. A Proof-of-Concept Pilot Test of a Behavioral Intervention to Improve Adherence to Dietary Recommendations for Cancer Prevention. Cancer Control. 2023 Jan-Dec;30:10732748231214122. doi: 10.1177/10732748231214122.

Reference Type DERIVED
PMID: 37950612 (View on PubMed)

Horgan OZ, Crane NT, Forman EM, Milliron BJ, Simone NL, Zhang F, Butryn ML. Optimizing an mHealth Intervention to Change Food Purchasing Behaviors for Cancer Prevention: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 24;11(6):e39669. doi: 10.2196/39669.

Reference Type DERIVED
PMID: 35749216 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R21CA252933

Identifier Type: NIH

Identifier Source: secondary_id

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1R21CA252933

Identifier Type: NIH

Identifier Source: org_study_id

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