Encouraging Young Adults to Make Effective Nutrition Choices (MENU Gen-Y)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Henry Ford Health System
Sponsor:
Collaborators:
Geisinger Clinic
University of Michigan
Information provided by (Responsible Party):
Gwen Alexander, PhD, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01979809
First received: November 4, 2013
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to conduct a two site, three arm randomized intervention study to improve fruit and vegetable intake, improve whole grain intake and reduce sweetened beverages in young adults aged 21 to 30 years. This work is potentially very high impact in light of growing overweight and obesity and decreased health status overall, and potential dietary benefits to children of our target age group.


Condition Intervention
Improve Dietary Behaviors in Young Adults 21-30 Years of Age
Behavioral: MENU GenY

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Encouraging Young Adults to Make Effective Nutrition Choices: MENU Gen Y Study

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Change in fruit and vegetable intake at 12 months post enrollment, 2-item screener and CDC 24 hour screener [ Time Frame: Primary assessm't is 12 months post enrollment ] [ Designated as safety issue: No ]
    Using the 2-item fruit and vegetable screener and CDC screener, which will be used to assess fruit and vegetable intake at baseline, 3 months, 6 months and 12 months. Also, to be examined is variation in dietary change by contextual factors including site, demographics, program engagement, environment, social and motivational factors.


Secondary Outcome Measures:
  • CDC screener to measure sweetened beverage intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compare baseline intake of sweetened beverages to assessments at 3 month, 6 month and 12 months post enrollment.

  • CDC screener to measure increase in whole grains [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Utilizling the CDC food screener, we will assess change in whole grain consumption at baseline and compare findings at 3 months, 6 months, and 12 monthspost enrollment.


Estimated Enrollment: 1624
Study Start Date: February 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Arm 1
Untailored control website designed to support increase in fruit and vegetables with no age targeting used in previously funded MENU Choices study
Behavioral: MENU GenY
Participants will assess eligibility, complete consent and baseline survey to enroll online, then be randomized to one of 3 arms: Control Arm 1 - a non-tailored intervention with no age targeting; Arm 2 -age targeted, tailored website set to appeal to young adults and offer a varety of support using muli-media to improve dietary intake of fruit, vegetables and whole grains, and decrease sweet drinks. Arm 3 utilizes the same intervention as Arm 2, and has support via email from eCoaches who use a Motivational Interview approach to support to help change dietary patterns. All arms are active for 4 months with occasionalemail contact throughout the following 8 mo. Follow-up surveys occur at 3 mo, 6 mo, and primary outcome at 12 months.
Other Names:
  • MENU Choices
  • MENU Gen-Y
  • Making Effective Nutrition Choices for Young Adults: the MENU Gen-Y Study
Active Comparator: Arm 2
MENU GenY age-targeted and tailored interactive website including 8 information sessions over 4 months, and options to visit over 185 recipes, videos, 4 bloggers, and information articles on dietary change topics
Behavioral: MENU GenY
Participants will assess eligibility, complete consent and baseline survey to enroll online, then be randomized to one of 3 arms: Control Arm 1 - a non-tailored intervention with no age targeting; Arm 2 -age targeted, tailored website set to appeal to young adults and offer a varety of support using muli-media to improve dietary intake of fruit, vegetables and whole grains, and decrease sweet drinks. Arm 3 utilizes the same intervention as Arm 2, and has support via email from eCoaches who use a Motivational Interview approach to support to help change dietary patterns. All arms are active for 4 months with occasionalemail contact throughout the following 8 mo. Follow-up surveys occur at 3 mo, 6 mo, and primary outcome at 12 months.
Other Names:
  • MENU Choices
  • MENU Gen-Y
  • Making Effective Nutrition Choices for Young Adults: the MENU Gen-Y Study
Active Comparator: Arm 3
Web intervention that is age targeted and tailored, identical to Arm 2, with the addition of personalized "e-coaching" support via email.
Behavioral: MENU GenY
Participants will assess eligibility, complete consent and baseline survey to enroll online, then be randomized to one of 3 arms: Control Arm 1 - a non-tailored intervention with no age targeting; Arm 2 -age targeted, tailored website set to appeal to young adults and offer a varety of support using muli-media to improve dietary intake of fruit, vegetables and whole grains, and decrease sweet drinks. Arm 3 utilizes the same intervention as Arm 2, and has support via email from eCoaches who use a Motivational Interview approach to support to help change dietary patterns. All arms are active for 4 months with occasionalemail contact throughout the following 8 mo. Follow-up surveys occur at 3 mo, 6 mo, and primary outcome at 12 months.
Other Names:
  • MENU Choices
  • MENU Gen-Y
  • Making Effective Nutrition Choices for Young Adults: the MENU Gen-Y Study

Detailed Description:

In support of NIH goals to improve people's health and support a healthy lifestyle, we will conduct a randomized trial to evaluate an age-targeted web-based intervention designed to improve the diet of a young adults (ages 21-30) as they navigate a new life stage of greater independence. The goal of our study is to increase daily intake of fruits and vegetables(FV) for young adults born in or after 1980, known as "Generation Y" (GenY), using relevant features that appeal to this group. This five-year project has two phases. In the first phase, we will use focus groups to confirm planned, key intervention elements that target needs and preferences of GenY and will build engagement in the intervention, as we revise our tested, effective Internet- based intervention (Making Effective Nutrition Choices or MENU, U19-CA079689). The MENU study was designed to support an increase in FV intake, and relied solely on e-media (internet and email). In the proposed study we will revise the MENU curriculum, applying age-targeted and theory-based methods to improve intervention engagement and effectiveness for GenY dietary behavior change. The intervention will use three psychosocial features which have been subject to empirical examination by age group: Social Cognitive Theory, Self-Determination Theory (SDT), with special attention to Social Marketing Theory(SMT), which emphasizes understanding the total environment to better shape health communications.

In developing our program, we will apply knowledge about GenY from developmental psychology,guided by our consultants and formative research on individual, environmental and societal factors collected in our preliminary studies and Phase I GenY focus groups. Focus group members will evaluate our validated MENU intervention, as well as our revised age-targeted, interactive "MENU GenY" intervention prior to launch. In the second phase, we will evaluate the efficacy of the MENU GenY interventions, including the added value of the self-initiated, personalized e-coaching support by email, as a supplement to the tailored online intervention. Specifically, using a sample of 1624 adults,ages 21 - 30 and from two geographically distinct regions (urban Detroit and rural Pennsylvania), and employing a randomized, three arm design, the primary aims of Phase II are to 1) determine if an agetargeted,tailored web-based intervention is more efficacious in improving primary outcome of daily intake of FV compared to an untailored intervention arm with no age targeting (control arm); 2) determine if a tailored webbased intervention with age targeting and personalized e-coaching support is more efficacious than the control; and 3) determine if the tailored web-based intervention with age targeting and e-counseling is more efficacious than a tailored web-based intervention with age targeting alone.

  Eligibility

Ages Eligible for Study:   21 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21-30 years of age
  • receive medical care from Henry Ford Health System (Detroit, MI) or Geisinger Health System (Danville area and central Pennsylvania)

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979809

Contacts
Contact: Gwen Alexander, Ph.D (313)874-6737 galexan2@hfhs.org
Contact: Michelle Groesbeck, BA (313)874-6361 mgroesb1@hfhs.org

Locations
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Gwen Alexander, Ph.D    313-874-6737    galexan2@hfhs.org   
Contact: Michelle Groesbeck, BA    (313)874-6361    mgroesb1@hfhs.org   
Principal Investigator: Gwen Alexander, Ph.D         
United States, Pennsylvania
Geisinger Health System Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Margaret Rukstalis, Ph.D    570-214-9825    margaret.rukstalis@icloud.com   
Contact: Ashley Ryman    570-214-5229    amryman1@geisinger.edu   
Principal Investigator: Margaret Rukstalis, M.D.         
Sponsors and Collaborators
Henry Ford Health System
Geisinger Clinic
University of Michigan
Investigators
Principal Investigator: Gwen Alexander, Ph.D Henry Ford Health System
  More Information

No publications provided

Responsible Party: Gwen Alexander, PhD, Assistant Research Scientist, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01979809     History of Changes
Other Study ID Numbers: 1 R01 HD067314-01A1
Study First Received: November 4, 2013
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Dietary change
Young adult
Prevention
Web-based intervention
eCoaching

ClinicalTrials.gov processed this record on October 19, 2014