Think AHEAD (A Healthy Eating And Drinking) Study
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.
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02115
- Children's Hospital Boston
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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).
|
Participants will receive personalized dietary counseling to promote behavior change
|
|
Aktywny komparator: 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.
|
Participants will receive personalized dietary counseling to promote behavior change
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Body mass index
Ramy czasowe: 6 month change
|
6 month change
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Body fat percentage
Ramy czasowe: 6 month change
|
6 month change
|
|
Body circumferences
Ramy czasowe: 6 month change
|
6 month change
|
|
Urine specific gravity
Ramy czasowe: Change throughout 6 months
|
Change throughout 6 months
|
|
Hunger, satiety, and palatability ratings
Ramy czasowe: 6 month change
|
6 month change
|
|
Diet quality
Ramy czasowe: 6 month change
|
6 month change
|
|
Satisfaction rating
Ramy czasowe: 6 months
|
6 months
|
|
Immune status
Ramy czasowe: 6 month change
|
6 month change
|
|
Cardiovascular risk factors
Ramy czasowe: 6 month change
|
6 month change
|
|
Diabetes risk factors
Ramy czasowe: 6 month change
|
6 month change
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- X09-11-0587
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Dietary counseling
-
Sheba Medical CenterZakończony