Clinical trial NCT01979809: Encouraging Young Adults to Make Effective Nutrition Choices
Official title: Encouraging Young Adults to Make Effective Nutrition Choices: MENU GenY Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improve Dietary Behaviors in Young Adults 21-30 Years of Age
Keywords: Dietary change
Young adult
Prevention
Web-based intervention
eCoaching
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Geisinger Clinic
name: University of Michigan
First posted: 2013-11-08
Enrollment: 1674
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

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 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:

Primary outcomes:
measure: Change in fruit and vegetable intake at 12 months post enrollment, 2-item screener and CDC 24 hour screener
timeFrame: Primary assessm't is 12 months post enrollment
Secondary outcomes:
measure: CDC screener to measure sweetened beverage intake
timeFrame: 12 months
measure: CDC screener to measure increase in whole grains
timeFrame: 12 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
Study officials:
affiliation: Henry Ford Health System
name: Gwen Alexander, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: