This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Get Fruved: Obesity Prevention for Older Adolescents

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Sarah Colby, The University of Tennessee, Knoxville
Sponsor:
Collaborators:
United States Department of Agriculture (USDA)
University of Florida
West Virginia University
South Dakota State University
Auburn University
Syracuse University
University of Maine
Kansas State University
Information provided by (Responsible Party):
Sarah Colby, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier:
NCT02941497
First received: October 18, 2016
Last updated: October 20, 2016
Last verified: October 2016
  Purpose

This program is a non-diet approach to obesity prevention for older adolescents which does not promote following a special diet to manage weight; instead, it promotes healthy behavior associated with obesity prevention. This approach is especially important with youth and older adolescent populations so as 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) will use 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 college tool kit will be disseminated to additional college campuses. In year 05, the program will be disseminated to additional high schools.

The nine month interactive, social marketing environmental intervention will aid older adolescents in effectively managing weight 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.


Condition Intervention
Obesity Behavioral: Social marketing and health promotion campaign

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: "Get Fruved:" A Peer-led, Train-the-trainer Social Marketing Intervention to Increase Fruit and Vegetable Intake and Prevent Childhood Obesity.

Further study details as provided by Sarah Colby, The University of Tennessee, Knoxville:

Primary Outcome Measures:
  • Body weight [ Time Frame: Change in body weight from baseline to six months and one year follow up ]
    Following an overnight fast and voiding, weight is measured in light clothing without shoes and with pockets emptied. Weight is measured in duplicate (average used unless > 0.1 kg difference requiring re-measurement until 2 values within range are achieved) to the nearest 0.1 kilograms using a calibrated electronic scale by trained assessors. Height without shoes is measured to the nearest 0.1 centimeter using a portable stadiometer. Height and weight are used to calculate BMI.


Secondary Outcome Measures:
  • Amount of physical activity [ Time Frame: Change in amount of physical activity from baseline to six months and one year follow up ]
    The International Physical Activity Questionnaire (IPAQ) is used to measure self-reported physical activity. Results are calculated as Metabolic Equivalent (MET) minutes/week and can be used to estimate energy expenditure.

  • Dietary quality [ Time Frame: Change in dietary quality from baseline to six months and one year follow up ]
    The Automated Self-Administered Recall System (ASA24) is a web-based tool that allows participants to complete 24-hour recalls online. The Researcher Web site is used to incorporate the recall process in assessments and analyze data. Subjects complete the initial 24-hour recall at the time of the in-person physical assessment. They then receive email prompts asking them to completed two follow-up 24 hour recalls within the same week for a total of two recalls on nonconsecutive weekdays and one weekend day.

  • Fruit and vegetable intake [ Time Frame: Change in fruit and vegetable intake from baseline to six months and one year follow up ]
    Cups of fruits and vegetables/day is assessed using the NCI Fruit and Vegetable Screener (FVS). The FVS is a 19-item instrument that includes assessment of portion size.

  • Body composition [ Time Frame: Change in body composition from baseline to six months and one year follow up ]
    All circumference measurements are done using a Gulick tape measure. The waist is measured at the level of the iliac crests. The hips are measured at the maximum extension of the buttocks, and used to calculate body adiposity index (9) and hip to waist ratio. The neck is measured at the level of the Adams apple which can be palpated to identify location.

  • Eating competence [ Time Frame: Change in eating competence from baseline to six months and one year follow up ]
    Eating competence is measured using ecSatter Inventory (ecSI). The ecSI consists of 16 items that measure eating attitudes, food acceptance, internal regulation, and contextual skills such as meal planning. Those who have higher eating competence scores are more likely to be satisfied with weight, have lower BMI, and consume more fruits and vegetables than those with lower eating competence scores.

  • Quality of life [ Time Frame: Change in quality of life from baseline to six months and one year follow up ]
    Quality of life is measured using two self-reported questionnaires the 12-Item General Health Questionnaire and the Brief Multidimensional Student Life Satisfaction Survey (BMSLSS). The 12-Item General Health Questionnaire is a measure of current mental health and psychological stress and has been used in different settings, cultures, and with young adults. The BMSLSS is a self-reported assessment of satisfaction with family, friends, school, self and environment.

  • Stress [ Time Frame: Change in stress from baseline to six months and one year follow up ]
    Perceived stress is measured Cohen's Perceived Stress Scale (PSS). The PSS is a 14 item instrument designed to measure the degree to which situations in one's life are appraised as stressful.

  • Behavior changeability [ Time Frame: Change in perceptions and willingness to change from baseline to six months and one year follow up ]
    The Behavioral Environmental Changeability Survey (BECS) was developed and is used to assess perceptions of the importance and willingness to change weight related behavior. The BECS consists of eight scales (Nutrition Changeability; Nutrition Behavior; Environmental Changeability; Program Importance and Changeability; Exercise Behavior; Sleep Behavior and Importance; Weight Loss; and Alcohol Intake).

  • Sleep [ Time Frame: Change in sleep from baseline to six months and one year follow up ]
    Quality and quantity of sleep are assessed using the Pittsburg Sleep Quality Index (PSQI). The survey has 19 self-reported items related to sleep over the past month. The items generate seven component scores (sleep quality, sleep latency, duration, efficiency, disturbances, use of sleeping medication and daytime dysfunction) which are summed for a global PSQI score.

  • Campus healthy food access [ Time Frame: Change in campus food choice from baseline to six months and one year follow up ]
    Changes in overall consumption of all foods on campus are evaluated by reviewing the ordering records (with control for total student population) and sales data for all vending and dining services.

  • Environmental change [ Time Frame: Change in the campus environment from baseline to six months and one year follow up ]
    The changes in the environment are assessed using the Healthy Campus Audit and the CEPS. The HCA assesses physical activity, food, and policy aspects of the environment.

  • Recreational facility usage [ Time Frame: Change in recreational facility usage from baseline to six months and one year follow up ]
    The use of the recreational facilities are assessed through reviewing entrance records (with control for total student population).


Estimated Enrollment: 5800
Study Start Date: August 2014
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive intervention group
The intensive intervention group participates in development and implementation of the social marketing and health promotion campaign and peer-led campus activities and is assessed for their health-related behaviors. This was Wave 1 in colleges in Yr 01-02 and is being repeated as Wave 2 in colleges in Yr 03. This will also be repeated in high schools in Yr 04.
Behavioral: Social marketing and health promotion campaign
Students in the intensive intervention group developed a nine-month social marketing health campaign. The campaign included five costumed characters who interacted with students on campus in residence halls, dining halls, and other highly-trafficked public areas on campus. Photos and videos of interactions were put on social media. Student participants from the general population (the diffuse intervention group) were asked to set weekly healthy goals related to diet, physical activity, and stress management throughout the campaign and received email and text messages with goal-specific written and video health-promotion messages. Faculty partnered with the students throughout the intervention process to educate and give advice on the content of health promotion messages.
Other Name: Get Fruved
Experimental: Diffuse intervention group
The diffuse intervention group receives the social marketing and health promotion campaign and participates in the peer-led campus activities and is assessed for their health related behaviors, but is not involved in the design and delivery of the intervention materials and activities. This was Wave 1 in colleges in Yr 01-02 and is being repeated as Wave 2 in colleges in Yr 03. This will also be repeated in high schools in Yr 04.
Behavioral: Social marketing and health promotion campaign
Students in the intensive intervention group developed a nine-month social marketing health campaign. The campaign included five costumed characters who interacted with students on campus in residence halls, dining halls, and other highly-trafficked public areas on campus. Photos and videos of interactions were put on social media. Student participants from the general population (the diffuse intervention group) were asked to set weekly healthy goals related to diet, physical activity, and stress management throughout the campaign and received email and text messages with goal-specific written and video health-promotion messages. Faculty partnered with the students throughout the intervention process to educate and give advice on the content of health promotion messages.
Other Name: Get Fruved

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  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: NCT02941497

Contacts
Contact: Sarah Colby, PhD, RD 865-974-6248 scolby1@utk.edu
Contact: Anne Mathews, PhD, RDN 352-294-3719 anne.mathews@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Anne Mathews, PhD, RDN    352-294-3719    anne.mathews@ufl.edu   
Principal Investigator: Anne Mathews, PhD, RDN         
United States, Kansas
Kansas State University Recruiting
Manhattan, Kansas, United States, 66506
Contact: Tandalayo Kidd, PhD, RD    785-532-0154    martan@k-state.edu   
Principal Investigator: Tandalayo Kidd, PhD, RD         
United States, Maine
University of Maine Recruiting
Orono, Maine, United States, 04469
Contact: Adrienne White, PhD, RD    207-581-3134    awhite@maine.edu   
Principal Investigator: Adrienne White, PhD, RD         
United States, New York
Syracuse University Recruiting
Syracuse, New York, United States, 13244
Contact: Tanya Horacek, PhD, RD    315-443-9323    thoracek@syr.edu   
Principal Investigator: Tanya Horacek, PhD, RD         
United States, South Dakota
South Dakota State University Recruiting
Brookings, South Dakota, United States, 57007
Contact: Kendra Kattelmann, PhD, RDN    605-688-4045    Kendra.kattelmann@sdstate.edu   
Principal Investigator: Kendra Kattelmann, PhD, RDN         
United States, Tennessee
University of Tennessee Recruiting
Knoxville, Tennessee, United States, 37996
Contact: Sarah Colby, PhD, RD    865-974-6248    scolby1@utk.edu   
Contact: Kerri Martin, PhD    865-312-4725    kmarti50@utk.edu   
Principal Investigator: Sarah Colby, PhD         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Melissa Olfert, DrPH, RDN    304-293-1918    Melissa.Olfert@mail.wvu.edu   
Principal Investigator: Melissa Olfert, DrPH, RDN         
Sponsors and Collaborators
The University of Tennessee, Knoxville
United States Department of Agriculture (USDA)
University of Florida
West Virginia University
South Dakota State University
Auburn University
Syracuse University
University of Maine
Kansas State University
Investigators
Principal Investigator: Sarah Colby, PhD, RD University of Tennessee
  More Information

Additional Information:
Publications:
Szymona K, Quick V, Olfert M, et al. The University Environment: A Comprehensive Assessment of Health-Related Advertisements. Health Ed. 2012;112(6):497-512.

Responsible Party: Sarah Colby, Associate Professor, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier: NCT02941497     History of Changes
Other Study ID Numbers: UTK IRB-14-09366 B-XP
2014-67001-21851 ( Other Grant/Funding Number: USDA National Institute of Food and Agriculture A2101 )
WBS number R011770127 ( Other Identifier: University of Tennessee )
Study First Received: October 18, 2016
Last Updated: October 20, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan at this time.

Keywords provided by Sarah Colby, The University of Tennessee, Knoxville:
Stress, Psychological
Obesity
Physical Activity
Fruit
Vegetables
Social Marketing
Peer Influence
Community-Based Participatory Research

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2017