Think AHEAD (A Healthy Eating And Drinking) Study - Full Text View

Sponsor:	Children's Hospital Boston
Information provided by:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT01044134

Purpose

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.

Condition	Intervention
Obesity	Behavioral: Dietary counseling

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 6-Month Study on Diet and Weight Loss in Overweight Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

Body mass index [ Time Frame: 6 month change ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body fat percentage [ Time Frame: 6 month change ] [ Designated as safety issue: No ]
Body circumferences [ Time Frame: 6 month change ] [ Designated as safety issue: No ]
Urine specific gravity [ Time Frame: Change throughout 6 months ] [ Designated as safety issue: No ]
Hunger, satiety, and palatability ratings [ Time Frame: 6 month change ] [ Designated as safety issue: No ]
Diet quality [ Time Frame: 6 month change ] [ Designated as safety issue: No ]
Satisfaction rating [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Immune status [ Time Frame: 6 month change ] [ Designated as safety issue: No ]
Cardiovascular risk factors [ Time Frame: 6 month change ] [ Designated as safety issue: No ]
Diabetes risk factors [ Time Frame: 6 month change ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	February 2011
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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).	Behavioral: Dietary counseling Participants will receive personalized dietary counseling to promote behavior change
Active Comparator: 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.	Behavioral: Dietary counseling Participants will receive personalized dietary counseling to promote behavior change

Arms

Assigned Interventions

Experimental: 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).

Behavioral: Dietary counseling

Participants will receive personalized dietary counseling to promote behavior change

Active Comparator: 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.

Behavioral: Dietary counseling

Participants will receive personalized dietary counseling to promote behavior change

Detailed Description:

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, cooking demonstrations, 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.

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044134

Contacts

Contact: Julia Wong, PhD	617 355-7703	julia.wong@childrens.harvard.edu
Contact: Meredith Beard	617 355-6097	meredith.beard@childrens.harvard.edu

Locations

United States, Massachusetts
Children's Hospital Boston	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Julia Wong, PhD 617-355-7703 julia.wong@childrens.harvard.edu
Sub-Investigator: Cara B Ebbeling, PhD

Sponsors and Collaborators

Children's Hospital Boston

Investigators

Principal Investigator:

David S Ludwig, MD, PhD

Children's Hospital Boston

More Information

No publications provided

Responsible Party:	David S Ludwig, MD, PhD, Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT01044134 History of Changes
Other Study ID Numbers:	X09-11-0587
Study First Received:	January 5, 2010
Last Updated:	April 20, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 21, 2012