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Think AHEAD (A Healthy Eating And Drinking) Study

27 luglio 2015 aggiornato da: David S. Ludwig, MD, PhD, Boston Children's Hospital

A 6-Month Study on Diet and Weight Loss in Overweight Adolescents

Advice to increase water consumption as part of a weight-reducing diet - typically to 8 cups (64 fl oz, ~2 L) per day ("8x8" water recommendation) - is almost ubiquitously recommended by healthcare professionals. Many believe that water promotes weight loss through numerous physiological mechanisms. However, only limited observational data and virtually no experimental data exist regarding the effects of water consumption on body weight. In this study, we propose a randomized controlled pilot study in which two groups of overweight adolescents will receive a standard weight loss regimen, either with (experimental intervention) or without (control intervention) additional advice and support to increase water consumption. We will utilize individual sessions, an innovative text messaging protocol, and motivational telephone calls to promote adherence to the interventions. The purpose of this pilot study is to evaluate feasibility and obtain preliminary efficacy data, to inform design of a future, definitive study.

It is hypothesized that increasing water consumption will improve the efficacy of a standard weight-reducing diet and will lead to decreased consumption of energy-containing beverages, decreased total energy intake, improved diet quality, improved immune status, and improved cardiovascular and diabetes risk factors. This simple behavioral intervention will be feasible and will significantly increase water consumption among participants in the experimental vs. control group.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a 6-month randomized controlled trial. After the initial baseline screening and assessments, 60 overweight adolescents will be randomly assigned (30 subjects per group) to a standard weight-reducing diet with the advice to consume 8 cups of water per day (experimental group) or the same standard weight-reducing diet without additional advice (control group). The interventions will consist of nutrition education and behavioral counseling by a registered dietitian, during individual sessions and telephone calls. Mobile text messaging will be used to reinforce information presented at the individual sessions and thereby foster adherence to dietary advice. Diet prescriptions will differ only in regard to the specificity of recommendations regarding water consumption and physical activity recommendations will not differ between groups. The frequency and content of text messages will be consistent between the experimental and control groups, with the exception that the experimental group will receive an additional phrase with each message to encourage the "8 x8" water recommendation.

A registered dietitian will communicate with each participant one time per month, either during an individual session or by telephone. Individual sessions will include nutrition classes, taste testing, hands-on activities, and opportunities for questions and answers. Text messages will be sent on a daily basis.

Study outcomes will be assessed at baseline and at regular intervals throughout the 6 months of the study.

ANALYSIS PLAN:

The blinding of the randomization will be broken on or after July 28, 2014 and the data will be analyzed according to the following plan. All analyses will follow the intention-to-treat principle, attributing each subject to his or her assigned diet regardless of compliance. Baseline characteristics will be compared between the diet groups using the Fisher exact test for categorical variables and t-test for continuous variables. The 6-month change from baseline in the primary and secondary outcomes will be compared between groups using a general linear model, adjusting for baseline covariates that are potentially correlated with the outcome. These include demographics, socioeconomic status, anthropometrics, physical activity, and beverage consumption. We will further test covariates for potential interaction, i.e., differential effect on outcome in the two trial arms. The null hypothesis is that the 6-month change from baseline will not differ between diet groups.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

38

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02115
        • Children's Hospital Boston

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 17 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • BMI ≥ 85th percentile for sex and age according to CDC growth charts
  • Access to a working telephone and cell phone
  • At least one parent willing and able to participate in the intervention with the subject
  • Residing in predominately one household (no more than one weekend every two weeks in a secondary household)
  • Medical clearance from a primary care provider or treating physician to rule out any major medical illness, disability, or disorder (e.g., liver disease, renal failure, cancer)

Exclusion Criteria:

  • Intake of more than 4 cups (250 mL per cup) of water per day
  • BMI ≥ 40 kg/m2
  • Currently smoking (> 1 cigarette in the past week)
  • Major surgery within the previous 6 months
  • Does not have a primary care provider
  • Physician diagnosis of a major medical illness (e.g. diabetes)
  • Previous diagnosis of an eating disorder
  • Physical, mental, or cognitive handicaps that prevent participation
  • Chronic use of medications that may affect study outcomes (e.g. stimulants or diuretics)
  • Another member of the family (first degree relative) or household participating in the study
  • A friend, classmate or coworker participating in the study with whom they have contact with one or more times per week
  • Girls who are pregnant, planning to become pregnant in the next 6 months, lactating, or within 6 months postpartum

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Diet + Water
Participants will be counseled to follow a standard weight-reducing diet including consumption of 1) ample vegetables, fruits, and legumes; 2) whole rather than refined grains; and 3) high-quality proteins at most meals and snacks. Moreover, we will recommend limiting intake of added fats and sugars and avoiding juices and sugar-sweetened beverages (per standard practice). Participants will also be counseled to increase their water intake to 8 cups per day, consistent with the popular "8 × 8" recommendation (eight 8-oz glasses of water).
Comportamentale: Dietary counseling
Participants will receive personalized dietary counseling to promote behavior change
Comparatore attivo: Diet
Participants will be counseled on the same standard weight-reducing diet, as described above, with no specific advice regarding water consumption. Furthermore, no specific dietary recommendations will be provided on altering fluid/beverage intake, other than to decrease calorie-containing beverages as noted above. When participants ask for a recommendation regarding water intake, they will be advised that drinking plain water is the best way to satisfy thirst and instructed to drink when thirsty.
Comportamentale: Dietary counseling
Participants will receive personalized dietary counseling to promote behavior change

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Body mass index
Lasso di tempo: 6 month change
6 month change

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Body fat percentage
Lasso di tempo: 6 month change
6 month change
Body circumferences
Lasso di tempo: 6 month change
6 month change
Urine specific gravity
Lasso di tempo: Change throughout 6 months
Change throughout 6 months
Hunger, satiety, and palatability ratings
Lasso di tempo: 6 month change
6 month change
Diet quality
Lasso di tempo: 6 month change
6 month change
Satisfaction rating
Lasso di tempo: 6 months
6 months
Immune status
Lasso di tempo: 6 month change
6 month change
Cardiovascular risk factors
Lasso di tempo: 6 month change
6 month change
Diabetes risk factors
Lasso di tempo: 6 month change
6 month change

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boston Children's Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2011

Completamento primario (Effettivo)

1 giugno 2014

Completamento dello studio (Effettivo)

1 giugno 2014

Date di iscrizione allo studio

Primo inviato

5 gennaio 2010

Primo inviato che soddisfa i criteri di controllo qualità

5 gennaio 2010

Primo Inserito (Stima)

7 gennaio 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 luglio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 luglio 2015

Ultimo verificato

1 luglio 2015

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • X09-11-0587

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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