Family Based Treatment for Weight Loss With Breakfast Prescription (FAB)
16. oktober 2017 opdateret af: Kerri Boutelle, University of California, San Diego
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
66
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
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La Jolla, California, Forenede Stater, 92037
- Center for Healthy Eating and Activity Research
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
8 år til 12 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Family Based Behavioral Treatment Egg
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
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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.
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Aktiv komparator: Family Based Behavioral Treatment Cereal
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.
|
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Ratings of acceptability intervention
Tidsramme: 4 months
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4 months
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Ratings of liking intervention
Tidsramme: 4 months
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4 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Child weight
Tidsramme: 8 months
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Measured by Body Mass Index (BMI)
|
8 months
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Parent weight
Tidsramme: 8 months
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Measured by Body Mass Index (BMI)
|
8 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Bowen 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.
- Rolls 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.
- Layman 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.
- Epstein 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.
- Halton 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.
- Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
- Holt SH, Miller JC, Petocz P, Farmakalidis E. A satiety index of common foods. Eur J Clin Nutr. 1995 Sep;49(9):675-90.
- Shikany 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.
- Piech 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.
- Hagan 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.
- Vander 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.
- Layman 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.
- Blouet 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.
- Zhang 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.
- Cummings 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.
- Vander Wal JS, Gupta A, Khosla P, Dhurandhar NV. Egg breakfast enhances weight loss. Int J Obes (Lond). 2008 Oct;32(10):1545-51. doi: 10.1038/ijo.2008.130. Epub 2008 Aug 5.
- Lomenick JP, Melguizo MS, Mitchell SL, Summar ML, Anderson JW. Effects of meals high in carbohydrate, protein, and fat on ghrelin and peptide YY secretion in prepubertal children. J Clin Endocrinol Metab. 2009 Nov;94(11):4463-71. doi: 10.1210/jc.2009-0949. Epub 2009 Oct 9.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2014
Primær færdiggørelse (Faktiske)
1. september 2017
Studieafslutning (Faktiske)
1. september 2017
Datoer for studieregistrering
Først indsendt
28. oktober 2014
Først indsendt, der opfyldte QC-kriterier
8. juni 2015
Først opslået (Skøn)
9. juni 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. oktober 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. oktober 2017
Sidst verificeret
1. oktober 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 131519
- 20133198 (Andet bevillings-/finansieringsnummer: American Egg Board)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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