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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Decrease Condition | Experimental | In 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 Condition | Experimental | Families will be encouraged to increase fruits and vegetables and decrease snack foods. Receives: Behavioral: Increase Fruits and Vegetables and Decrease Snack Foods |
| Increase Condition | Experimental | A 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.
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)
Change in Anthropometrics
child and parent height, weight, BMI, and z-BMI
Measured: baseline and 6 months
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
Change in Parenting Styles
Assesses practices associated with different parenting styles
Measured: baseline and 6 months
Change in Eating Pathology
Kids eating disorder survey and eating in the absence of hunger survey
Measured: baseline and 6 months
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
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.
- First posted16 Jan 2012 (estimated)
- Study startJan 2012
- Primary completion31 Dec 2018
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie Raynor, PhD, RD, Principal investigator, University of Tennessee
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 19363514Ebbeling 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 21041601Davis 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 18055653Cohen 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 20402200Kral 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 18407923Carter 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 18378876Golan 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 14995056Birch LL, Fisher JO. Development of eating behaviors among children and adolescents. Pediatrics. 1998 Mar;101(3 Pt 2):539-49.
PubMed 12224660Spear 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 16567146Butryn 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 15856498Neumark-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 19237105Epstein 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 11953732Epstein 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 15699222Epstein 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 15946114Epstein 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three Different Dietary Messages on Dietary Intake and Health in Families
- ClinicalTrials.gov ID
- NCT01510678
- Acronym / sponsor ID
- 8721-B
- Conditions
- Obesity
- Keywords
- Diet Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Jan 2012 (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.
Examine the effect of three different dietary messages on dietary intake and the health of parents and their children.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Decrease Condition | Experimental | Behavioral: Decrease Snack FoodsIn 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. |
| Increase + Decrease Condition | Experimental | Behavioral: Increase Fruits and Vegetables and Decrease Snack FoodsFamilies will be encouraged to increase fruits and vegetables and decrease snack foods. |
| Increase Condition | Experimental | Behavioral: Increase Fruits and VegetablesA 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Increase Fruits and VegetablesChildren 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. | Behavioural | Increase Condition |
| Decrease Snack FoodsThis 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. | Behavioural | Decrease Condition |
| Increase Fruits and Vegetables and Decrease Snack FoodsWill combine the goals of the increase and decrease conditions. | Behavioural | Increase + Decrease Condition |
Primary outcome
Change in Dietary intake
Time frame: baseline and 6 months
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).
6 secondary outcomes
Change in Anthropometrics
Time frame: baseline and 6 months
Change in Parent Feeding Styles
Time frame: baseline and 6 months
Change in Parenting Styles
Time frame: baseline and 6 months
Change in Eating Pathology
Time frame: baseline and 6 months
Change in Physical Activity
Time frame: baseline and 6 months
Change in Obesogenic Home Food Availability
Time frame: baseline and 6 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 9 Jun 2026.
- Background: PubMed 19363514Birch 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.
- Background: PubMed 21041601Ebbeling 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.
- Background: PubMed 18055653Davis 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.
- Background: PubMed 20402200Cohen 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.
- Background: PubMed 18407923Kral 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.
- Background: PubMed 18378876Carter 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.
- Background: PubMed 14995056Golan 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.
- Background: PubMed 12224660Birch LL, Fisher JO. Development of eating behaviors among children and adolescents. Pediatrics. 1998 Mar;101(3 Pt 2):539-49.
- Background: PubMed 16567146Spear 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.
- Background: PubMed 15856498Butryn 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.
- Background: PubMed 19237105Neumark-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.
- Background: PubMed 11953732Epstein 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.
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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.
Hollie Raynor, PhD, RD principal investigator
University of Tennessee
2 sites in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.