NCT02941497

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,800

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

6 years

First QC Date

October 18, 2016

Last Update Submit

January 27, 2020

Conditions

Keywords

Stress, PsychologicalObesityPhysical ActivityFruitVegetablesSocial MarketingPeer InfluenceCommunity-Based Participatory Research

Outcome Measures

Primary Outcomes (1)

  • Body weight

    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.

    Change in body weight from baseline to six months and one year follow up

Secondary Outcomes (11)

  • Amount of physical activity

    Change in amount of physical activity from baseline to six months and one year follow up

  • Dietary quality

    Change in dietary quality from baseline to six months and one year follow up

  • Fruit and vegetable intake

    Change in fruit and vegetable intake from baseline to six months and one year follow up

  • Body composition

    Change in body composition from baseline to six months and one year follow up

  • Eating competence

    Change in eating competence from baseline to six months and one year follow up

  • +6 more secondary outcomes

Study Arms (2)

Intensive intervention group

EXPERIMENTAL

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

Diffuse intervention group

EXPERIMENTAL

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

Interventions

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.

Also known as: Get Fruved
Diffuse intervention groupIntensive intervention group

Eligibility Criteria

AgeUp to 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Students who are not at-risk for health issues are excluded from the diffuse intervention group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Florida

Gainesville, Florida, 32611, United States

Location

Kansas State University

Manhattan, Kansas, 66506, United States

Location

University of Maine

Orono, Maine, 04469, United States

Location

Syracuse University

Syracuse, New York, 13244, United States

Location

South Dakota State University

Brookings, South Dakota, 57007, United States

Location

University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (15)

  • Byrd-Bredbenner C, Johnson M, Quick VM, Walsh J, Greene GW, Hoerr S, Colby SM, Kattelmann KK, Phillips BW, Kidd T, Horacek TM. Sweet and salty. An assessment of the snacks and beverages sold in vending machines on US post-secondary institution campuses. Appetite. 2012 Jun;58(3):1143-51. doi: 10.1016/j.appet.2012.02.055. Epub 2012 Mar 10.

    PMID: 22414787BACKGROUND
  • Do M, Kattelmann K, Boeckner L, Greene G, White A, Hoerr S, Horacek T, Lohse B, Phillips B, Nitzke S. Low-income young adults report increased variety in fruit and vegetable intake after a stage-tailored intervention. Nutr Res. 2008 Aug;28(8):517-22. doi: 10.1016/j.nutres.2008.05.013.

    PMID: 19083454BACKGROUND
  • Gordon R, McDermott L, Stead M, Angus K. The effectiveness of social marketing interventions for health improvement: what's the evidence? Public Health. 2006 Dec;120(12):1133-9. doi: 10.1016/j.puhe.2006.10.008. Epub 2006 Nov 13.

    PMID: 17095026BACKGROUND
  • Gracia-Marco L, Vicente-Rodriguez G, Borys JM, Le Bodo Y, Pettigrew S, Moreno LA. Contribution of social marketing strategies to community-based obesity prevention programmes in children. Int J Obes (Lond). 2011 Apr;35(4):472-9. doi: 10.1038/ijo.2010.221. Epub 2010 Oct 26.

    PMID: 20975724BACKGROUND
  • Greene GW, Schembre SM, White AA, Hoerr SL, Lohse B, Shoff S, Horacek T, Riebe D, Patterson J, Phillips BW, Kattelmann KK, Blissmer B. Identifying clusters of college students at elevated health risk based on eating and exercise behaviors and psychosocial determinants of body weight. J Am Diet Assoc. 2011 Mar;111(3):394-400. doi: 10.1016/j.jada.2010.11.011.

    PMID: 21338738BACKGROUND
  • Horacek TM, Erdman MB, Byrd-Bredbenner C, Carey G, Colby SM, Greene GW, Guo W, Kattelmann KK, Olfert M, Walsh J, White AB. Assessment of the dining environment on and near the campuses of fifteen post-secondary institutions. Public Health Nutr. 2013 Jul;16(7):1186-96. doi: 10.1017/S1368980012004454. Epub 2012 Oct 17.

    PMID: 23174458BACKGROUND
  • Horacek TM, White AA, Greene GW, Reznar MM, Quick VM, Morrell JS, Colby SM, Kattelmann KK, Herrick MS, Shelnutt KP, Mathews A, Phillips BW, Byrd-Bredbenner C. Sneakers and spokes: an assessment of the walkability and bikeability of U.S. postsecondary institutions. J Environ Health. 2012 Mar;74(7):8-15; quiz 42.

    PMID: 22428317BACKGROUND
  • O'Toole TP, Aaron KF, Chin MH, Horowitz C, Tyson F. Community-based participatory research: opportunities, challenges, and the need for a common language. J Gen Intern Med. 2003 Jul;18(7):592-4. doi: 10.1046/j.1525-1497.2003.30416.x. No abstract available.

    PMID: 12848844BACKGROUND
  • Schultz JT, Moodie M, Mavoa H, Utter J, Snowdon W, McCabe MP, Millar L, Kremer P, Swinburn BA. Experiences and challenges in implementing complex community-based research project: the Pacific Obesity Prevention in Communities project. Obes Rev. 2011 Nov;12 Suppl 2:12-9. doi: 10.1111/j.1467-789X.2011.00911.x.

    PMID: 22008555BACKGROUND
  • 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.

    BACKGROUND
  • El Zein A, Colby SE, Zhou W, Shelnutt KP, Greene GW, Horacek TM, Olfert MD, Mathews AE. Food Insecurity Is Associated with Increased Risk of Obesity in US College Students. Curr Dev Nutr. 2020 Jul 15;4(8):nzaa120. doi: 10.1093/cdn/nzaa120. eCollection 2020 Aug.

  • Olfert MD, Barr ML, Mathews AE, Horacek TM, Riggsbee K, Zhou W, Colby SE. Life of a vegetarian college student: Health, lifestyle, and environmental perceptions. J Am Coll Health. 2022 Jan;70(1):232-239. doi: 10.1080/07448481.2020.1740231. Epub 2020 Apr 28.

  • El Zein A, Shelnutt KP, Colby S, Vilaro MJ, Zhou W, Greene G, Olfert MD, Riggsbee K, Morrell JS, Mathews AE. Prevalence and correlates of food insecurity among U.S. college students: a multi-institutional study. BMC Public Health. 2019 May 29;19(1):660. doi: 10.1186/s12889-019-6943-6.

  • Famodu OA, Barr ML, Holaskova I, Zhou W, Morrell JS, Colby SE, Olfert MD. Shortening of the Pittsburgh Sleep Quality Index Survey Using Factor Analysis. Sleep Disord. 2018 Apr 12;2018:9643937. doi: 10.1155/2018/9643937. eCollection 2018.

  • Loso J, Staub D, Colby SE, Olfert MD, Kattelmann K, Vilaro M, Colee J, Zhou W, Franzen-Castle L, Mathews AE. Gardening Experience Is Associated with Increased Fruit and Vegetable Intake among First-Year College Students: A Cross-Sectional Examination. J Acad Nutr Diet. 2018 Feb;118(2):275-283. doi: 10.1016/j.jand.2017.09.005. Epub 2017 Dec 1.

Related Links

MeSH Terms

Conditions

ObesityStress, PsychologicalMotor Activity

Interventions

Social Marketing

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MarketingCommerceTechnology, Industry, and AgricultureMarketing of Health ServicesHealth Services AccessibilityDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Sarah Colby, PhD, RD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 21, 2016

Study Start

August 1, 2014

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

There is no plan at this time.

Locations