Think AHEAD (A Healthy Eating And Drinking) Study

This study has been terminated.
(We achieved n=38, due to slow recruitment (=2/3 of target). The absence of drop-outs and missing data will enhance power despite the smaller than expected n.)
Sponsor:
Information provided by (Responsible Party):
David S. Ludwig, MD, PhD, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01044134
First received: January 5, 2010
Last updated: July 21, 2014
Last verified: July 2014
  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:


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 ]

Enrollment: 38
Study Start Date: February 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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

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, 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
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, Professor, 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: July 21, 2014
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 August 21, 2014