ObesityFABNCT02467036
Family Based Treatment for Weight Loss With Breakfast Prescription
A study testing Family Based Behavioral Treatment in people with Obesity and Overweight, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether a behavioral weight loss group in conjunction with a prescribed breakfast can help children between 8 and 12 years of age change their behaviors to help them lose weight and become healthier. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Overeating
- What is being tested?
- Family Based Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2017
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 8 and 12 years old;
- BMI ≥85th% and <100% overweight
- Children with parents who are willing to attend 16 weekly group sessions and be randomized to either treatment arm;
- Have at least one parent who is overweight or obese (BMI≥25);
- Children and parent who endorse liking of both eggs and cereal
- Parents who speak English at a 5th grade level.
Who cannot join
- Children with serious medical conditions that affect their weight;
- Children taking medication that affect appetite or weight;
- Children with severe developmental delay or disability that would affect participation;
- Children or parents with psychological illness that would limit treatment participation;
- Families who plan to move out of the area within the time frame of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Healthy Eating and Activity Research
La Jolla, California, 92037
About this study
Official title: A Pilot Study Examining the Impact of Eggs for Breakfast on Weight Loss and Hunger in Obese Children
The purpose of this study is to evaluate whether a behavioral weight loss group in conjunction with a prescribed breakfast can help children between 8 and 12 years of age change their behaviors to help them lose weight and become healthier.
Read the detailed description
The purpose of this application is to evaluate the acceptability and initial efficacy of consumption of an egg breakfast, compared to a cereal breakfast, in the context of Family-based Behavioral Treatment (FBT) with overweight and obese children and their parents. Investigators will randomize 66 parents and their overweight and obese child (85-99.9%BMI) to FBT+egg or FBT+cereal groups. Families will eat their assigned breakfast (eggs or cereal) 5 out of 7 days during the 4 month FBT treatment. However, all other aspects of FBT will be the same in the two groups. Children and parents will complete assessments at three time points; baseline, post-treatment and 4-months post-treatment.
- Conditions
- Obesity, Overweight, Overeating, Weight, Childhood Obesity
- Being tested
- Family Based Behavioral Treatment
- Keywords
- overweight children, overweight parents, eating in the absence of hunger, families with overweight child, bmi, body mass index, treatment, behavioral treatment, family based treatment, experiments, intervention, psychophysiological response to food cues
- Medical subject headings
- Obesity, Overweight, Hyperphagia, Body Weight, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Based Behavioral TreatmentBehavioural
The intervention for both groups will be a 4-month Family-Based Behavioral Treatment (FBT), which includes dietary changes, physical activity changes, and behavioral therapy. Treatment is provided in separate parent and child groups. Families will learn to reduce caloric consumption and increase caloric expenditure (physical activity). Behavior therapy includes stimulus control, self-monitoring, goal setting and contracting, parenting skills, skills for managing high-risk situations, and maintenance and relapse prevention. Families will self-monitor caloric intake, breakfast consumption, physical activity, and hunger and satiety throughout the day.
| Study group | Role | What they receive |
|---|---|---|
| Family Based Behavioral Treatment Egg | Experimental | The FBT+Egg group will participate in group-based FBT and will be assigned to eat eggs a minimum of 5 days a week for breakfast. Families are provided eggs each week to facilitate compliance, along with recipes Receives: Behavioral: Family Based Behavioral Treatment |
| Family Based Behavioral Treatment Cereal | Active comparator | The FBT+Cereal group will participate in group-based FBT and will be assigned to eat cereal a minimum of 5 days a week for breakfast. Families are provided cereal each week to facilitate compliance. Receives: Behavioral: Family Based Behavioral Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratings of acceptability intervention
Measured: 4 months
Ratings of liking intervention
Measured: 4 months
Secondary outcomes (2)
Child weight
Measured by Body Mass Index (BMI)
Measured: 8 months
Parent weight
Measured by Body Mass Index (BMI)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Kerri Boutelle, University of California, San Diego
- Investigators
- Kerri Boutelle, Ph.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467036
- Sponsor's protocol ID
- 131519
- Other IDs
- 20133198
- Acronym
- FAB
- Status last verified
- Oct 2017
- First submitted
- 28 Oct 2014
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
PubMed 8646260Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year outcomes of behavioral family-based treatment for childhood obesity. Health Psychol. 1994 Sep;13(5):373-83. doi: 10.1037//0278-6133.13.5.373.
PubMed 7805631Shikany JM, Thomas SE, Henson CS, Redden DT, Heimburger DC. Glycemic index and glycemic load of popular weight-loss diets. MedGenMed. 2006 Jan 25;8(1):22.
PubMed 16915152Halton TL, Hu FB. The effects of high protein diets on thermogenesis, satiety and weight loss: a critical review. J Am Coll Nutr. 2004 Oct;23(5):373-85. doi: 10.1080/07315724.2004.10719381.
PubMed 15466943Piech RM, Pastorino MT, Zald DH. All I saw was the cake. Hunger effects on attentional capture by visual food cues. Appetite. 2010 Jun;54(3):579-82. doi: 10.1016/j.appet.2009.11.003. Epub 2009 Nov 13.
PubMed 19914320Hagan MM, Wauford PK, Chandler PC, Jarrett LA, Rybak RJ, Blackburn K. A new animal model of binge eating: key synergistic role of past caloric restriction and stress. Physiol Behav. 2002 Sep;77(1):45-54. doi: 10.1016/s0031-9384(02)00809-0.
PubMed 12213501Bowen J, Noakes M, Clifton PM. Appetite regulatory hormone responses to various dietary proteins differ by body mass index status despite similar reductions in ad libitum energy intake. J Clin Endocrinol Metab. 2006 Aug;91(8):2913-9. doi: 10.1210/jc.2006-0609. Epub 2006 May 30.
PubMed 16735482Rolls BJ, Hetherington M, Burley VJ. The specificity of satiety: the influence of foods of different macronutrient content on the development of satiety. Physiol Behav. 1988;43(2):145-53. doi: 10.1016/0031-9384(88)90230-2.
PubMed 3212049Holt SH, Miller JC, Petocz P, Farmakalidis E. A satiety index of common foods. Eur J Clin Nutr. 1995 Sep;49(9):675-90.
PubMed 7498104Vander Wal JS, Marth JM, Khosla P, Jen KL, Dhurandhar NV. Short-term effect of eggs on satiety in overweight and obese subjects. J Am Coll Nutr. 2005 Dec;24(6):510-5. doi: 10.1080/07315724.2005.10719497.
PubMed 16373948Layman DK, Walker DA. Potential importance of leucine in treatment of obesity and the metabolic syndrome. J Nutr. 2006 Jan;136(1 Suppl):319S-23S. doi: 10.1093/jn/136.1.319S.
PubMed 16365106Blouet C, Jo YH, Li X, Schwartz GJ. Mediobasal hypothalamic leucine sensing regulates food intake through activation of a hypothalamus-brainstem circuit. J Neurosci. 2009 Jul 1;29(26):8302-11. doi: 10.1523/JNEUROSCI.1668-09.2009.
PubMed 19571121Layman DK. The role of leucine in weight loss diets and glucose homeostasis. J Nutr. 2003 Jan;133(1):261S-267S. doi: 10.1093/jn/133.1.261S.
PubMed 12514305Zhang Y, Guo K, LeBlanc RE, Loh D, Schwartz GJ, Yu YH. Increasing dietary leucine intake reduces diet-induced obesity and improves glucose and cholesterol metabolism in mice via multimechanisms. Diabetes. 2007 Jun;56(6):1647-54. doi: 10.2337/db07-0123. Epub 2007 Mar 14.
PubMed 17360978Cummings DM, Henes S, Kolasa KM, Olsson J, Collier D. Insulin resistance status: predicting weight response in overweight children. Arch Pediatr Adolesc Med. 2008 Aug;162(8):764-8. doi: 10.1001/archpedi.162.8.764.
PubMed 18678809
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining the Impact of Eggs for Breakfast on Weight Loss and Hunger in Obese Children
- ClinicalTrials.gov ID
- NCT02467036
- Acronym / sponsor ID
- FAB / 131519
- Conditions
- Obesity, Overweight, Overeating, Weight, Childhood Obesity
- Keywords
- overweight children, overweight parents, eating in the absence of hunger, families with overweight child, bmi, body mass index, treatment, behavioral treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- Jan 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 9 Jun 2015 (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.
The purpose of this study is to evaluate whether a behavioral weight loss group in conjunction with a prescribed breakfast can help children between 8 and 12 years of age change their behaviors to help them lose weight and become healthier.
Detailed description
The purpose of this application is to evaluate the acceptability and initial efficacy of consumption of an egg breakfast, compared to a cereal breakfast, in the context of Family-based Behavioral Treatment (FBT) with overweight and obese children and their parents. Investigators will randomize 66 parents and their overweight and obese child (85-99.9%BMI) to FBT+egg or FBT+cereal groups. Families will eat their assigned breakfast (eggs or cereal) 5 out of 7 days during the 4 month FBT treatment. However, all other aspects of FBT will be the same in the two groups. Children and parents will complete assessments at three time points; baseline, post-treatment and 4-months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Based Behavioral Treatment Egg | Experimental | Behavioral: Family Based Behavioral TreatmentThe FBT+Egg group will participate in group-based FBT and will be assigned to eat eggs a minimum of 5 days a week for breakfast. Families are provided eggs each week to facilitate compliance, along with recipes |
| Family Based Behavioral Treatment Cereal | Active comparator | Behavioral: Family Based Behavioral TreatmentThe FBT+Cereal group will participate in group-based FBT and will be assigned to eat cereal a minimum of 5 days a week for breakfast. Families are provided cereal each week to facilitate compliance. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children between the ages of 8 and 12 years old;
- BMI ≥85th% and <100% overweight
- Children with parents who are willing to attend 16 weekly group sessions and be randomized to either treatment arm;
- Have at least one parent who is overweight or obese (BMI≥25);
- Children and parent who endorse liking of both eggs and cereal
Key exclusion criteria (5 listed)
- Children with serious medical conditions that affect their weight;
- Children taking medication that affect appetite or weight;
- Children with severe developmental delay or disability that would affect participation;
- Children or parents with psychological illness that would limit treatment participation;
- Families who plan to move out of the area within the time frame of the study.
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 |
|---|---|---|
| Family Based Behavioral TreatmentThe intervention for both groups will be a 4-month Family-Based Behavioral Treatment (FBT), which includes dietary changes, physical activity changes, and behavioral therapy. Treatment is provided in separate parent and child groups. Families will learn to reduce caloric consumption and increase caloric expenditure (physical activity). Behavior therapy includes stimulus control, self-monitoring, goal setting and contracting, parenting skills, skills for managing high-risk situations, and maintenance and relapse prevention. Families will self-monitor caloric intake, breakfast consumption, physical activity, and hunger and satiety throughout the day. | Behavioural | Family Based Behavioral Treatment Cereal, Family Based Behavioral Treatment Egg |
Primary outcome
Ratings of acceptability intervention
Time frame: 4 months
Ratings of liking intervention
Time frame: 4 months
2 secondary outcomes
Child weight
Time frame: 8 months
Parent weight
Time frame: 8 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 18 Oct 2017.
- Background: PubMed 8646260Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
- Background: PubMed 7805631Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year outcomes of behavioral family-based treatment for childhood obesity. Health Psychol. 1994 Sep;13(5):373-83. doi: 10.1037//0278-6133.13.5.373.
- Background: PubMed 16915152Shikany JM, Thomas SE, Henson CS, Redden DT, Heimburger DC. Glycemic index and glycemic load of popular weight-loss diets. MedGenMed. 2006 Jan 25;8(1):22.
- Background: PubMed 15466943Halton TL, Hu FB. The effects of high protein diets on thermogenesis, satiety and weight loss: a critical review. J Am Coll Nutr. 2004 Oct;23(5):373-85. doi: 10.1080/07315724.2004.10719381.
- Background: PubMed 19914320Piech RM, Pastorino MT, Zald DH. All I saw was the cake. Hunger effects on attentional capture by visual food cues. Appetite. 2010 Jun;54(3):579-82. doi: 10.1016/j.appet.2009.11.003. Epub 2009 Nov 13.
- Background: PubMed 12213501Hagan MM, Wauford PK, Chandler PC, Jarrett LA, Rybak RJ, Blackburn K. A new animal model of binge eating: key synergistic role of past caloric restriction and stress. Physiol Behav. 2002 Sep;77(1):45-54. doi: 10.1016/s0031-9384(02)00809-0.
- Background: PubMed 16735482Bowen J, Noakes M, Clifton PM. Appetite regulatory hormone responses to various dietary proteins differ by body mass index status despite similar reductions in ad libitum energy intake. J Clin Endocrinol Metab. 2006 Aug;91(8):2913-9. doi: 10.1210/jc.2006-0609. Epub 2006 May 30.
- Background: PubMed 3212049Rolls BJ, Hetherington M, Burley VJ. The specificity of satiety: the influence of foods of different macronutrient content on the development of satiety. Physiol Behav. 1988;43(2):145-53. doi: 10.1016/0031-9384(88)90230-2.
- Background: PubMed 7498104Holt SH, Miller JC, Petocz P, Farmakalidis E. A satiety index of common foods. Eur J Clin Nutr. 1995 Sep;49(9):675-90.
- Background: PubMed 16373948Vander Wal JS, Marth JM, Khosla P, Jen KL, Dhurandhar NV. Short-term effect of eggs on satiety in overweight and obese subjects. J Am Coll Nutr. 2005 Dec;24(6):510-5. doi: 10.1080/07315724.2005.10719497.
- Background: PubMed 16365106Layman DK, Walker DA. Potential importance of leucine in treatment of obesity and the metabolic syndrome. J Nutr. 2006 Jan;136(1 Suppl):319S-23S. doi: 10.1093/jn/136.1.319S.
- Background: PubMed 19571121Blouet C, Jo YH, Li X, Schwartz GJ. Mediobasal hypothalamic leucine sensing regulates food intake through activation of a hypothalamus-brainstem circuit. J Neurosci. 2009 Jul 1;29(26):8302-11. doi: 10.1523/JNEUROSCI.1668-09.2009.
- Individual participant dataSharing planned: No
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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.
Kerri Boutelle, Ph.D. principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Based Behavioral Treatment in people with Obesity and Overweight, run by University of California, San Diego at 1 site 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 5 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 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Ratings of acceptability intervention (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT02467036, which also lists 17 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 18 Oct 2017.