Think AHEAD (A Healthy Eating And Drinking) Study

NCT01044134 | Terminated

• 1 other identifier: X09-11-0587
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Body mass index

  6 month change

Secondary Outcomes (9)

• Body fat percentage

  6 month change

• Body circumferences

  6 month change

• Urine specific gravity

  Change throughout 6 months

• Hunger, satiety, and palatability ratings

  6 month change

• Diet quality

  6 month change

Study Arms (2)

Diet + Water

EXPERIMENTAL

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

Diet

ACTIVE COMPARATOR

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

Interventions

Dietary counseling BEHAVIORAL

Participants will receive personalized dietary counseling to promote behavior change

Diet; Diet + Water

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Wong JMW, Ebbeling CB, Robinson L, Feldman HA, Ludwig DS. Effects of Advice to Drink 8 Cups of Water per Day in Adolescents With Overweight or Obesity: A Randomized Clinical Trial. JAMA Pediatr. 2017 May 1;171(5):e170012. doi: 10.1001/jamapediatrics.2017.0012. Epub 2017 May 1.

  PMID: 28264082 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• David S Ludwig, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: February 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

US (1)