Improve Dietary Behaviors in Young Adults 21-30 Years of AgeMENU GenYNCT01979809
Encouraging Young Adults to Make Effective Nutrition Choices
A study testing MENU GenY in people with Improve Dietary Behaviors in Young Adults 21-30 Years of Age, run by Henry Ford Health System at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Improve Dietary Behaviors in Young Adults 21-30 Years of Age
- What is being tested?
- MENU GenY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,674 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to 26 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-30 years of age
- receive medical care from Henry Ford Health System (Detroit, MI) or Geisinger Health System (Danville area and central Pennsylvania)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Geisinger Health System
Danville, Pennsylvania, 17822
Henry Ford Health System
Detroit, Michigan, 48202
About this study
Official title: Encouraging Young Adults to Make Effective Nutrition Choices: MENU GenY Study
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.
Read the 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.
- Being tested
- MENU GenY
- Keywords
- Dietary change, Young adult, Prevention, Web-based intervention, eCoaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MENU GenYBehavioural
Also called MENU Choices, MENU Gen-Y, Making Effective Nutrition Choices for Young Adults: the MENU Gen-Y Study
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Sham comparator | Untailored control website designed to support increase in fruit and vegetables with no age targeting used in previously funded MENU Choices study Receives: Behavioral: MENU GenY |
| Arm 2 | Active comparator | 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 Receives: Behavioral: MENU GenY |
| Arm 3 | Active comparator | Web intervention that is age targeted and tailored, identical to Arm 2, with the addition of personalized "e-coaching" support via email. Receives: Behavioral: MENU GenY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fruit and vegetable intake at 12 months post enrollment, 2-item screener and CDC 24 hour screener
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.
Measured: Primary assessm't is 12 months post enrollment
Secondary outcomes (2)
CDC screener to measure sweetened beverage intake
Compare baseline intake of sweetened beverages to assessments at 3 month, 6 month and 12 months post enrollment.
Measured: 12 months
CDC screener to measure increase in whole grains
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completion26 May 2016
- Study completion26 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improve Dietary Behaviors in Young Adults 21-30 Years of AgeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Geisinger Clinic, University of Michigan
- Responsible party
- Principal investigator, Gwen Alexander, PhD, Henry Ford Health System
- Investigators
- Gwen Alexander, Ph.D, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979809
- Sponsor's protocol ID
- 1R01HD067314-01A1
- Acronym
- MENU GenY
- Status last verified
- Feb 2017
- First submitted
- 4 Nov 2013
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouraging Young Adults to Make Effective Nutrition Choices: MENU GenY Study
- ClinicalTrials.gov ID
- NCT01979809
- Acronym / sponsor ID
- MENU GenY / 1R01HD067314-01A1
- Keywords
- Dietary change, Young adult, Prevention, Web-based intervention, eCoaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,674 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Geisinger Clinic, University of Michigan
- Study start
- Feb 2014 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 26 May 2016 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Sham comparator | Behavioral: MENU GenYUntailored control website designed to support increase in fruit and vegetables with no age targeting used in previously funded MENU Choices study |
| Arm 2 | Active comparator | Behavioral: MENU GenYMENU 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 |
| Arm 3 | Active comparator | Behavioral: MENU GenYWeb intervention that is age targeted and tailored, identical to Arm 2, with the addition of personalized "e-coaching" support via email. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 21-30 years of age
- receive medical care from Henry Ford Health System (Detroit, MI) or Geisinger Health System (Danville area and central Pennsylvania)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MENU GenYAlso: MENU Choices, MENU Gen-Y, Making Effective Nutrition Choices for Young Adults: the MENU Gen-Y StudyParticipants 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. | Behavioural | Arm 1, Arm 2, Arm 3 |
Primary outcome
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
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.
2 secondary outcomes
CDC screener to measure sweetened beverage intake
Time frame: 12 months
CDC screener to measure increase in whole grains
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwen Alexander, Ph.D principal investigator
Henry Ford Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MENU GenY in people with Improve Dietary Behaviors in Young Adults 21-30 Years of Age, run by Henry Ford Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.