ObesityNCT01044134
Think AHEAD (A Healthy Eating And Drinking) Study
A study testing Dietary counseling in people with Obesity, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dietary counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Dietary counseling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary counselingBehavioural
Participants will receive personalized dietary counseling to promote behavior change
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Measured: 6 month change
Secondary outcomes (9)
Body fat percentage
Measured: 6 month change
Body circumferences
Measured: 6 month change
Urine specific gravity
Measured: Change throughout 6 months
Hunger, satiety, and palatability ratings
Measured: 6 month change
Diet quality
Measured: 6 month change
Satisfaction rating
Measured: 6 months
Immune status
Measured: 6 month change
Cardiovascular risk factors
Measured: 6 month change
Diabetes risk factors
Measured: 6 month change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startFeb 2011
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: We achieved n=38, due to slow recruitment (=2/3 of target).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David S. Ludwig, MD, PhD, Boston Children's Hospital
- Investigators
- David S Ludwig, MD, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044134
- Sponsor's protocol ID
- X09-11-0587
- Status last verified
- Jul 2015
- First submitted
- 5 Jan 2010
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28264082
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month Study on Diet and Weight Loss in Overweight Adolescents
- ClinicalTrials.gov ID
- NCT01044134
- Acronym / sponsor ID
- X09-11-0587
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We achieved n=38, due to slow recruitment (=2/3 of target).
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet + Water | Experimental | Behavioral: Dietary counselingParticipants 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). |
| Diet | Active comparator | Behavioral: Dietary counselingParticipants 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary counselingParticipants will receive personalized dietary counseling to promote behavior change | Behavioural | Diet, Diet + Water |
Primary outcome
Body mass index
Time frame: 6 month change
9 secondary outcomes
Body fat percentage
Time frame: 6 month change
Body circumferences
Time frame: 6 month change
Urine specific gravity
Time frame: Change throughout 6 months
Hunger, satiety, and palatability ratings
Time frame: 6 month change
Diet quality
Time frame: 6 month change
Satisfaction rating
Time frame: 6 months
Immune status
Time frame: 6 month change
Cardiovascular risk factors
Time frame: 6 month change
Diabetes risk factors
Time frame: 6 month change
Results and safety
The study was stopped early (reason given: We achieved n=38, due to slow recruitment (=2/3 of target).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Derived from this study: PubMed 28264082Wong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Ludwig, MD, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary counseling in people with Obesity, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We achieved n=38, due to slow recruitment (=2/3 of target).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 6 month change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01044134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.