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Diet and Weight Loss in Young Adults - NCT01044134-02115(Clinical Trial 464258)



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City:  Boston
State:  
MA
Zip Code: 02115
Conditions: Obesity
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 obese young adults 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 group 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, and improved diet quality. This simple behavioral intervention will be feasible and will significantly increase water consumption among participants in the experimental vs. control group.
Study summary: This is a 6-month randomized controlled trial. After the initial baseline screening and assessments, 60 obese young adults 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 group workshops and telephone calls. Mobile text messaging will be used to reinforce information presented at the group workshops 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. Participants will attend a series of monthly group workshops which include nutrition classes taught by a registered dietitian, cooking demonstrations, taste testing, hands-on activities and opportunities for questions and answers. A registered dietitian will also call participants every month to follow-up on their progress on the intervention they were assigned to and 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.
Criteria: Inclusion Criteria: - Body mass index (BMI) ≥30 and <40 kg/m2 - Willing and able to attend group workshops on specified evenings - Access to a working telephone and cell phone - Medical clearance from a primary care provider to rule out any major medical illness, disability, or disorder Exclusion Criteria: - Intake of more than 4 cups (250 mL per cup) of water per day - Adherence to a weight loss diet within the previous 6 months - Alcohol intake (more than 7 drinks per week; 1 drink will be defined as 12 oz beer, 5 oz wine, or 1.5 oz liquor) - 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 - Previous diagnosis of an eating disorder - Physical, mental, or cognitive handicaps that prevent participation - Chronic use of medications that may affect study outcomes - Another member of the family (first degree relative) or household participating in the study - A friend or co-worker participating in the study with whom they have contact one or more times per week - Women who are pregnant, planning to become pregnant in the next 6 months, lactating, or within 6 months postpartum
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2011
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