Clinical trial NCT02941497: Get Fruved: Obesity Prevention for Older Adolescents
Official title: "Get Fruved:" A Peer-led, Train-the-trainer Social Marketing Intervention to Increase Fruit and Vegetable Intake and Prevent Childhood Obesity.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Stress, Psychological
Obesity
Physical Activity
Fruit
Vegetables
Social Marketing
Peer Influence
Community-Based Participatory Research
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
name: University of Florida
name: West Virginia University
name: South Dakota State University
name: Auburn University
name: Syracuse University
name: University of Maine
name: Kansas State University
First posted: 2016-10-21
Enrollment: 5800
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This program is a non-diet approach to obesity prevention for older adolescents which does not promote following a special diet to manage weight; it promotes healthy behavior associated with obesity prevention. This approach is important with youth and older adolescent populations to avoid impairment in emotional well-being associated with body dissatisfaction. Healthy weight status will be achieved by improving dietary intake patterns, increasing physical activity, and improving stress management. Fall of year 01 was devoted to the recruitment of student partners (intense intervention group) and the development of partnerships. In the spring of year 01, recruited students were enrolled in two newly developed undergraduate courses across four intervention state partners, became collegiate 4-H members, planned a social marketing campaign, and/or learned to be peer mentors or student researchers. In year 02, first year college students were recruited, peer mentors were matched with a group of first year students, and the developed social marketing campaign was pilot tested on four college campuses (diffuse intervention) by the collegiate 4-H teams. In year 02, a toolkit with 24 weeks of intervention activities was also refined. In year 03, the collegiate 4-H team (intense intervention group) used the refined toolkit to test and implement the intervention on college campuses. In year 03, the assessment process for high school 4-H students (intense intervention group) will be pilot tested and college students will work with the high school students on adapting the toolkit for use in the implementation of the social marketing campaign in high school settings in year 04 (diffuse intervention). ). In year 04, the pilot and feasibility tested college intervention was tested with a randomized control trial design with 30 intervention and 29 control university partners. The adapted high school toolkit was pilot and feasibility tested in three intervention and two control high school settings. In year 05, the high school intervention was tested with a randomized control trial design with 9 intervention and 7 control high schools in one district's high schools. On all measures it is anticipated that participants in the intensive intervention group will have greater improvements than those in the diffuse intervention group and both intensive and diffuse intervention groups will have improvements over those in the control groups.

Detailed description: The goal of the research is to develop a novel strategy to promote healthy behaviors associated with obesity prevention in older adolescent populations. A community based participatory research (CBPR) approach is used with partnerships among older adolescents, university researchers and faculty, and Extension partners. The objective is to test the effectiveness of a peer-led, train-the-trainer intervention. The intervention is an interactive, non-traditional social marketing, online media, and environmental change approach seeking to promote healthy behavior with communities of college and high school students. Specific health behaviors targeted include increasing intakes of fruits and vegetables, decreasing foods high in saturated fats and added sugars, managing stress, and increasing physical activity. This project uniquely 1) increases participant engagement through creative interactions, participant-created content, and incorporation of age-appropriate technology; 2) incorporates social environments and peer-led strategies; and 3) simultaneously addresses changes in environments to support participant-driven behavior change efforts.

This project is a Pretest-Posttest, Control Group Trial using a nested cohort design with three conditions (intense intervention, diffuse intervention, and control), four control universities and four intervention universities in years 01- 03, one high school as control and one as intervention at each of the four intervention university towns in years 03-04, and disseminated to four additional university and high school pairs in years 04-05.

A CBPR, peer-led approach is used in that upper level college students mentor freshmen 4-H college students through the development of the intervention. The CBPR, peer-led approach continues when the now sophomore 4-H college students implement the intervention with incoming college freshmen in the following year. The train-the-trainer approach is utilized when the now junior level 4-H college students mentor 4-H high school students in the modification of the intervention for high schools. The approach continues when 4-H high school students implement the intervention with incoming freshmen in high schools.

In the fall of year 01, 283 freshman students were recruited from general/survey nutrition courses at the four intervention universities to participate in a special undergraduate spring course (the intense intervention group). 94 freshman students were also recruited from general/survey nutrition courses at the four control universities. During the fall, researchers at the intervention schools worked with nutrition (graduate and undergraduate) students to identify and develop partnerships with student organizations for the development of a social marketing health promotion campaign. Researchers and student partners also worked with local high schools (including student organizations, school food service, Parent Teacher Associations, school wellness committees, and administration) and school boards to formalize research agreements and relationships.

In the spring of year 01, as a part of the newly developed undergraduate course, the freshman students (the intense intervention group) from each intervention university joined their collegiate 4-H program. The courses were offered as independent studies or as a newly developed course through the respective University's PI. The course covered principals of social marketing for health behavior change. University researchers and Extension faculty collaborated and taught in-person classes with their respective collegiate 4-H students. Collegiate 4-H students were co-taught (by all four University's research and Extension faculty) and had the opportunity to interact with the other collegiate 4-H students from all four intervention universities through web-based technologies. Throughout the course, the collegiate 4-H students developed and planned a social marketing campaign. Following a peer-led approach, the 4-H students partnered with and were mentored by upper-level nutrition students and student organizations (student partners) in the development and planning of the campaign.

In year 02, the now sophomore collegiate 4-H students in the intense intervention group (receiving hourly compensation) worked with student partners to implement the developed nine-month social marketing campaign. The campaign centered around five costumed characters (Spinach, Carrot, Banana, Grapes, and Tomato). Characters interacted with students on campus in freshmen residence halls, dining halls/cafeterias and highly trafficked public areas on campus. Photos and videos of interactions were put on the website (www.fruved.com), Facebook, twitter, YouTube, Snap Chat, and Instagram. Online educational modules (focused on healthy diet patterns, physical activity, and stress management) will also become available on the website. Student participants from the general freshman population were asked to set weekly healthy goals related to diet, physical activity, and stress management throughout the campaign and receive email and/or text messages with goal-specific written and video health promotion messages. Extension faculty and staff partnered with the collegiate 4-H student teams throughout the intervention process to educate and give advice on the content of health promotion messages. Throughout the campaign, collegiate 4-H students worked with researchers to assess the healthiness of their campus environments using a previously developed Healthy Campus Audit and advocated for changes to the physical and food environment.

In year 02, a random sample of 1,153 freshmen (the diffuse intervention group), determined by screening to be at increased health risk were recruited from the eight universities (four intervention and four control). The collegiate 4-H students (the intense intervention group) and the same students from the control schools recruited in year 01 were reassessed.

In year 03, the collegiate 4-H team (intense intervention group) will use the refined toolkit to test and implement the intervention on college campuses. The sustainability of observed changes at the individual and environmental college level will be assessed by conducting follow-up assessments with the students in the intervention (the diffuse intervention group) and control sites at colleges in year 03. The collegiate 4-H students (the intensive intervention group) leading the project at the high school level and the same students from the control schools recruited in year 01 will be reassessed at the beginning of fall year 03, and end of spring year 03. Also in year 03, the assessment process for high school 4-H students (intense intervention group) will be piloted tested and college students will work with the high school students on adapting the toolkit for use in the implementation of the social marketing campaign in high school settings (diffuse intervention).

In year 04, two high schools in each of the four intervention University states participated in the research process and were randomized to control and intervention. High schools in each state were matched by size and community composition and geographically separated to prevent potential exposure to the campaign. Following the train-the-trainer model, teams of now junior collegiate 4-H students (the intense intervention group) mentored teams of high school 4-H students (the intense intervention group) at each of the intervention sites in the development and implementation of the Fruved campaign in the high school environment. In the fall, collegiate students will work with the high school students (the intense intervention group) to modify the campaign to meet the age and cultural needs of a high school audience and plan the specific campaign components. The high school 4-H teams will partner with their school's food service, Parent Teacher Association (PTA), school Wellness committee, and school administration throughout the campaign development, implementation, and evaluation. The campaign will be conducted in the intervention high schools over the remaining nine-month school year.

In year 04, a random sample of 331 freshman high school students (the diffuse intervention group) will be recruited from the intervention high schools and a random sample of 331 freshman high school students (the control group) from the control high schools in each of the four intervention University town areas. Assessments will take place in early fall and late spring. The 4-H high school students (intensive intervention group) recruited to participate in the design and implementation phases of the project will also be assessed in early fall/late spring in year 04.

Also in year 04, to continue to assess the sustainability of observed changes at the individual and environmental high school level, participants will be assessed by conducting follow-up assessments with the students in the intensive intervention group and control sites in high schools. The collegiate 4-H students (the intensive intervention group) that lead the project at the high school level and the same students from the control schools recruited in year 01 will be reassessed at the beginning of fall year 04 and end of spring year 04.

In year 04-05, materials will be developed allowing the project to be further disseminated to other college and high school environments. Four additional college and high school pairs will be recruited to participate in the dissemination phase. In year 04 the college students will receive training materials, study manual, costumes, cameras, and a small implementation budget but will not receive support for incentives or student 4-H compensation. The campaign will be developed and implemented over one school year. A modified project assessment will be required to be completed by the collegiate student 4H groups. In year 05 the collegiate 4-H students will work with high school 4-H students to develop and implement the project in high schools. The high school 4-H student group will complete the modified project assessments.

The nine month interactive, social marketing environmental intervention will aid older adolescents in effectively preventing obesity through increasing healthfulness of diet, increased physical activity, and improved stress management behavior as compared to a control group. On all measures it is anticipated that participants in the intensive intervention group will have greater improvements than those in the diffuse intervention group and both intensive and diffuse intervention groups will have improvements over those in the control groups. Students participating in the intervention will more effectively manage their weight than those in the non-intervention control condition; those participating in the intervention will improve intermediary outcomes related to diet, physical activity, and improved stress management to a greater extent than those in the control condition; and environments at intervention sites will show health behavior-supportive changes as compared to control sites.

Since there are more than two time intervals in the design, General Linear Modeling will be used to analyze for changes in physical assessments, specifically a mixed-model Analysis of variance and covariance (ANCOVA) if the group-specific slopes are homogeneous. A wide range of analyses will be employed to analyze the influence of the intervention on secondary outcomes, including multivariate analyses of variance (MANOVA), ANOVAs, and logistic regression. Significant ANOVAs will be followed up with tests of simple and main effects as appropriate. The intervention group-by-occasions interaction test will assess the impact of the intervention in the treatment group relative to the control group across time on the secondary outcome measures.

Eligibility criteria: Inclusion criteria:

* Students in the intensive intervention group must be registered for a general/survey nutrition or wellness course
* Students in the diffuse intervention group randomly selected from those who screen in because they are at increased health risk (increased BMI and waist circumference, low intakes of fruits and vegetables, high levels of stress, and low levels of physical activity)

Exclusion criteria:

* There are no exclusionary criteria for students in the intensive intervention group
* Students who are not at-risk for health issues are excluded from the diffuse intervention group

Primary outcomes:
measure: Body weight
timeFrame: Change in body weight from baseline to six months and one year follow up
Secondary outcomes:
measure: Amount of physical activity
timeFrame: Change in amount of physical activity from baseline to six months and one year follow up
measure: Dietary quality
timeFrame: Change in dietary quality from baseline to six months and one year follow up
measure: Fruit and vegetable intake
timeFrame: Change in fruit and vegetable intake from baseline to six months and one year follow up
measure: Body composition
timeFrame: Change in body composition from baseline to six months and one year follow up
measure: Eating competence
timeFrame: Change in eating competence from baseline to six months and one year follow up
measure: Stress
timeFrame: Change in stress from baseline to six months and one year follow up
measure: Behavior changeability
timeFrame: Change in perceptions and willingness to change from baseline to six months and one year follow up
measure: Sleep
timeFrame: Change in sleep from baseline to six months and one year follow up
measure: Campus healthy food access
timeFrame: Change in campus food choice from baseline to six months and one year follow up
measure: Environmental change
timeFrame: Change in the campus environment from baseline to six months and one year follow up
measure: Recreational facility usage
timeFrame: Change in recreational facility usage from baseline to six months and one year follow up
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Manhattan
country: United States
facility: Kansas State University
state: Kansas
city: Orono
country: United States
facility: University of Maine
state: Maine
city: Syracuse
country: United States
facility: Syracuse University
state: New York
city: Brookings
country: United States
facility: South Dakota State University
state: South Dakota
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Tennessee
name: Sarah Colby, PhD, RD
role: PRINCIPAL_INVESTIGATOR
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