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ObesityNCT01510678

The Effect of Three Different Dietary Messages on Dietary Intake and Health in Families

A study testing Increase Fruits and Vegetables, Decrease Snack Foods and Increase Fruits and Vegetables and Decrease Snack Foods in people with Obesity, run by The University of Tennessee, Knoxville at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Examine the effect of three different dietary messages on dietary intake and the health of parents and their children. Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Increase Fruits and Vegetables, Decrease Snack Foods and Increase Fruits and Vegetables and Decrease Snack Foods
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesUnited States
Study dates
Jan 2012to 31 Dec 2025
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 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children between ages 6-12 years
  • BMI percentile > 5th and < 85th percentile for age and sex
  • Have a parent aged > 21 years with a BMI > 25
  • Have an overweight/obese parent willing to attend intervention meetings
  • Parent and child speak and read English
  • Not moving out of the metropolitan area during the course of the investigation

Who cannot join

  • Reporting that the child and parent planning to participate have dietary restrictions related to fruit and vegetable intake
  • Physical activity restrictions
  • A parent reporting that she is pregnant, planning to become pregnant, or currently breastfeeding

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The University of Tennessee

    Knoxville, Tennessee, 37996-1920

  • Healthy Eating and Activity Laboratory, University of Tennessee

    Knoxville, Tennessee, 37996

Other trials in United States

About this study

Examine the effect of three different dietary messages on dietary intake and the health of parents and their children.

Read the detailed description

The goal of this pilot study is to conduct a randomized controlled trial examining three dietary messages: increase fruits and vegetables [INCREASE], decrease energy-dense, non-nutrient dense snack foods [DECREASE], or increase fruits and vegetables plus decrease snack foods [INCREASE+DECREASE], within a 6-month, family-based obesity prevention intervention. Each condition will also focus on increasing family evening meals and physical activity. Primary hypotheses are: 1) INCREASE + DECREASE will consume a greater ratio of F\&Vs:SFs than INCREASE and DECREASE at 6 months.

2)INCREASE + DECREASE will consume less energy than INCREASE and DECREASE at 6 months.

Conditions
Obesity
Being tested
Increase Fruits and Vegetables, Decrease Snack Foods, Increase Fruits and Vegetables and Decrease Snack Foods
Keywords
Diet Quality
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Increase Fruits and VegetablesBehavioural

    Children will be encouraged to consume 1 cup/day and 1.5 cups/day of whole fruit, and 1.5 cups/day and 2 cups/day of vegetables for children aged 6 to 8 years and 9 to 12 years, respectively. Children will gradually work towards these goals. Parents will also work towards F\&V goals, with 2 cups/day of whole fruit and 2.5 cups/day of vegetables. Both parent and child will self-monitor these behaviors. As one barrier to consuming F\&Vs is perceived cost of these foods, information regarding lower-cost options for F\&Vs will be included in the manual.

  • Decrease Snack FoodsBehavioural

    This condition will reduce intake of SFs (i.e., candy, cookies, cakes, ice cream, chips, nuts) to < 3 servings/week (for children aged 6 to 12 years, the solid fats and added sugar energy limit is 840 kcals/week and the DECREASE goal will help with meeting this limit). Children and parents will gradually work towards meeting these goals and self-monitor these behaviors.

  • Increase Fruits and Vegetables and Decrease Snack FoodsBehavioural

    Will combine the goals of the increase and decrease conditions.

Study groups in NCT01510678
Study groupRoleWhat they receive
Decrease ConditionExperimentalIn the Decrease Snack Foods condition participants will reduce intake of SFs (i.e., candy, cookies, cakes, ice cream, chips, nuts) to < 3 servings/week (for children aged 6 to 12 years, the solid fats and added sugar energy limit is 840 kcals/week and the DECREASE goal will help with meeting this limit). Children and parents will gradually work towards meeting these goals and self-monitor these behaviors.
Receives: Behavioral: Decrease Snack Foods
Increase + Decrease ConditionExperimentalFamilies will be encouraged to increase fruits and vegetables and decrease snack foods.
Receives: Behavioral: Increase Fruits and Vegetables and Decrease Snack Foods
Increase ConditionExperimentalA parent and child will be encouraged to increase fruits and vegetables. Children will be encouraged to consume 1 cup/day and 1.5 cups/day of whole fruit, and 1.5 cups/day and 2 cups/day of vegetables for children aged 6 to 8 years and 9 to 12 years, respectively. Children will gradually work towards these goals. Parents will also work towards F\&V goals, with 2 cups/day of whole fruit and 2.5 cups/day of vegetables.
Receives: Behavioral: Increase Fruits and Vegetables

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Dietary intake

    Changes in F\&Vs, SFs, energy density, overall energy, and percent energy from fat intake, will be assessed by a three-day food record (two weekdays, one weekend day).

    Measured: baseline and 6 months

Secondary outcomes (6)

  1. Change in Anthropometrics

    child and parent height, weight, BMI, and z-BMI

    Measured: baseline and 6 months

  2. Change in Parent Feeding Styles

    Includes 7 topics: perceived responsibility, perceived parent weight, perceived child weight, concern about child weight, restriction, pressure to eat, and monitoring.

    Measured: baseline and 6 months

  3. Change in Parenting Styles

    Assesses practices associated with different parenting styles

    Measured: baseline and 6 months

  4. Change in Eating Pathology

    Kids eating disorder survey and eating in the absence of hunger survey

    Measured: baseline and 6 months

  5. Change in Physical Activity

    Previous day physical activity recall- looks at 2 weekdays and 1 weekend day. For parents and children to complete

    Measured: baseline and 6 months

  6. Change in Obesogenic Home Food Availability

    self-report on foods that are available in the home.

    Measured: baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2025

Resources

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
Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01510678
Sponsor's protocol ID
8721-B
Status last verified
Jun 2026
First submitted
5 Jan 2012
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Birch LL, Ventura AK. Preventing childhood obesity: what works? Int J Obes (Lond). 2009 Apr;33 Suppl 1:S74-81. doi: 10.1038/ijo.2009.22.

    PubMed 19363514

  • Ebbeling CB, Ludwig DS. Pediatric obesity prevention initiatives: more questions than answers. Arch Pediatr Adolesc Med. 2010 Nov;164(11):1067-9. doi: 10.1001/archpediatrics.2010.186. No abstract available.

    PubMed 21041601

  • Davis MM, Gance-Cleveland B, Hassink S, Johnson R, Paradis G, Resnicow K. Recommendations for prevention of childhood obesity. Pediatrics. 2007 Dec;120 Suppl 4:S229-53. doi: 10.1542/peds.2007-2329E.

    PubMed 18055653

  • Cohen DA, Sturm R, Scott M, Farley TA, Bluthenthal R. Not enough fruit and vegetables or too many cookies, candies, salty snacks, and soft drinks? Public Health Rep. 2010 Jan-Feb;125(1):88-95. doi: 10.1177/003335491012500112.

    PubMed 20402200

  • Kral TV, Faith MS. Influences on child eating and weight development from a behavioral genetics perspective. J Pediatr Psychol. 2009 Jul;34(6):596-605. doi: 10.1093/jpepsy/jsn037. Epub 2008 Apr 10.

    PubMed 18407923

  • Carter FA, Bulik CM. Childhood obesity prevention programs: how do they affect eating pathology and other psychological measures? Psychosom Med. 2008 Apr;70(3):363-71. doi: 10.1097/PSY.0b013e318164f911. Epub 2008 Mar 31.

    PubMed 18378876

  • Golan M, Crow S. Parents are key players in the prevention and treatment of weight-related problems. Nutr Rev. 2004 Jan;62(1):39-50. doi: 10.1111/j.1753-4887.2004.tb00005.x.

    PubMed 14995056

  • Birch LL, Fisher JO. Development of eating behaviors among children and adolescents. Pediatrics. 1998 Mar;101(3 Pt 2):539-49.

    PubMed 12224660

  • Spear BA. Does dieting increase the risk for obesity and eating disorders? J Am Diet Assoc. 2006 Apr;106(4):523-5. doi: 10.1016/j.jada.2006.01.013. No abstract available.

    PubMed 16567146

  • Butryn ML, Wadden TA. Treatment of overweight in children and adolescents: does dieting increase the risk of eating disorders? Int J Eat Disord. 2005 May;37(4):285-93. doi: 10.1002/eat.20098.

    PubMed 15856498

  • Neumark-Sztainer D. Preventing obesity and eating disorders in adolescents: what can health care providers do? J Adolesc Health. 2009 Mar;44(3):206-13. doi: 10.1016/j.jadohealth.2008.11.005.

    PubMed 19237105

  • Epstein LH, Paluch RA, Consalvi A, Riordan K, Scholl T. Effects of manipulating sedentary behavior on physical activity and food intake. J Pediatr. 2002 Mar;140(3):334-9. doi: 10.1067/mpd.2002.122395.

    PubMed 11953732

  • Epstein LH, Roemmich JN, Paluch RA, Raynor HA. Influence of changes in sedentary behavior on energy and macronutrient intake in youth. Am J Clin Nutr. 2005 Feb;81(2):361-6. doi: 10.1093/ajcn.81.2.361.

    PubMed 15699222

  • Epstein LH, Roemmich JN, Paluch RA, Raynor HA. Physical activity as a substitute for sedentary behavior in youth. Ann Behav Med. 2005 Jun;29(3):200-9. doi: 10.1207/s15324796abm2903_6.

    PubMed 15946114

  • Epstein LH, Paluch RA, Beecher MD, Roemmich JN. Increasing healthy eating vs. reducing high energy-dense foods to treat pediatric obesity. Obesity (Silver Spring). 2008 Feb;16(2):318-26. doi: 10.1038/oby.2007.61.

    PubMed 18239639

Questions about this trial

What is this clinical trial studying?

A study testing Increase Fruits and Vegetables, Decrease Snack Foods and Increase Fruits and Vegetables and Decrease Snack Foods in people with Obesity, run by The University of Tennessee, Knoxville 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 6 inclusion and 3 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 9 Jun 2026. 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. 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 Dietary intake (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01510678, which also lists 36 linked publications.

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 9 Jun 2026.

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