ObesityNCT01598389
Eating Behaviors Among Weight-Discordant Siblings
A study testing Feeding study in people with Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study was to compare weight-discordant siblings in eating in the absence of hunger, caloric compensation, and the quality of their habitual diet. The investigator hypothesized that, within families and controlling for age differences, overweight and obese siblings would show greater eating in the… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Feeding study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to May 2011
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- same-sex;
- weight discordant (normal-weight vs. overweight/obese);
- meet age criteria;
- like most foods that were served in the study.
Who cannot join
- serious medical conditions or medication use known to affect appetite, food intake and body weight;
- developmental or psychiatric conditions;
- food allergies or nutrient intolerances (including lactose intolerance).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study was to compare weight-discordant siblings in eating in the absence of hunger, caloric compensation, and the quality of their habitual diet. The investigator hypothesized that, within families and controlling for age differences, overweight and obese siblings would show greater eating in the absence of hunger, poorer caloric compensation, and poorer diet quality (e.g., increased percent of energy from fat and caloric beverages) compared to normal-weight siblings.
Read the detailed description
The study used a discordant sibling design to compare putative obesity-promoting eating traits among siblings, 5-12 years, who were raised in the same household, but were discordant for weight status (normal-weight: BMI-for-age between 5 and less than the 85th percentile; overweight/obese: BMI-for-age greater or equal to the 85th percentile). Forty-seven pairs of same-sex siblings (boys and girls) were recruited from the greater Philadelphia area to participate in a 4-week study during which their eating behaviors and body composition were assessed. The study tested the hypotheses that overweight/obese, compared to normal-weight, siblings exhibit 1) a weaker ability to compensate for calories, 2) a greater susceptibility towards eating in the absence of hunger, and 3) habitual dietary intakes that favor increased dietary energy density (kcal/g) and increased %energy derived from fat and caloric beverages. The use of a behavioral genetics design to study eating phenotypes among siblings is a unique approach to elucidate shared and non-shared environmental influences that can contribute to variations in weight status during childhood.
- Conditions
- Obesity
- Being tested
- Feeding study
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding studyOther
In a crossover design, siblings were served dinner once a week for 3 weeks. Across conditions, siblings were served the same dinner, but, 25 minutes before dinner, they either consumed in full or did not consume one of two preloads that varied in energy density. On the day when no preload was consumed, eating in the absence of hunger was assessed after dinner and defined as the number of calories consumed from snacks. Habitual dietary intake was assessed using 24-hour dietary recalls.
| Study group | Role | What they receive |
|---|---|---|
| Low energy-dense preload | Experimental | Not described Receives: Other: Feeding study |
| High energy-dense preload | Experimental | Not described Receives: Other: Feeding study |
| No preload | Experimental | Not described Receives: Other: Feeding study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
%COMPX, EAH, dietary intake variables
Measured: Up to 4 weeks
Secondary outcomes (1)
Body composition
Weight status (BMI-for-age percentile), BMI z-score, total body fat (%), waist circumference (cm), skinfold thickness (mm)
Measured: Single assessment at Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startOct 2008
- Primary completionMay 2011
- Study completionMay 2011
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 University of PennsylvaniaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanja Kral, University of Pennsylvania
- Investigators
- Tanja V.E. Kral, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598389
- Sponsor's protocol ID
- K01DK078601
- Status last verified
- May 2012
- First submitted
- 8 May 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kral TV, Allison DB, Birch LL, Stallings VA, Moore RH, Faith MS. Caloric compensation and eating in the absence of hunger in 5- to 12-y-old weight-discordant siblings. Am J Clin Nutr. 2012 Sep;96(3):574-83. doi: 10.3945/ajcn.112.037952. Epub 2012 Aug 1.
PubMed 22854400
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Behaviors Among Weight-Discordant Siblings
- ClinicalTrials.gov ID
- NCT01598389
- Acronym / sponsor ID
- K01DK078601
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 May 2012 (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.
The purpose of this study was to compare weight-discordant siblings in eating in the absence of hunger, caloric compensation, and the quality of their habitual diet. The investigator hypothesized that, within families and controlling for age differences, overweight and obese siblings would show greater eating in the absence of hunger, poorer caloric compensation, and poorer diet quality (e.g., increased percent of energy from fat and caloric beverages) compared to normal-weight siblings.
Detailed description
The study used a discordant sibling design to compare putative obesity-promoting eating traits among siblings, 5-12 years, who were raised in the same household, but were discordant for weight status (normal-weight: BMI-for-age between 5 and less than the 85th percentile; overweight/obese: BMI-for-age greater or equal to the 85th percentile). Forty-seven pairs of same-sex siblings (boys and girls) were recruited from the greater Philadelphia area to participate in a 4-week study during which their eating behaviors and body composition were assessed. The study tested the hypotheses that overweight/obese, compared to normal-weight, siblings exhibit 1) a weaker ability to compensate for calories, 2) a greater susceptibility towards eating in the absence of hunger, and 3) habitual dietary intakes that favor increased dietary energy density (kcal/g) and increased %energy derived from fat and caloric beverages. The use of a behavioral genetics design to study eating phenotypes among siblings is a unique approach to elucidate shared and non-shared environmental influences that can contribute to variations in weight status during childhood.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low energy-dense preload | Experimental | Other: Feeding study |
| High energy-dense preload | Experimental | Other: Feeding study |
| No preload | Experimental | Other: Feeding study |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- same-sex;
- weight discordant (normal-weight vs. overweight/obese);
- meet age criteria;
- like most foods that were served in the study.
Key exclusion criteria (3 listed)
- serious medical conditions or medication use known to affect appetite, food intake and body weight;
- developmental or psychiatric conditions;
- food allergies or nutrient intolerances (including lactose intolerance).
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 |
|---|---|---|
| Feeding studyIn a crossover design, siblings were served dinner once a week for 3 weeks. Across conditions, siblings were served the same dinner, but, 25 minutes before dinner, they either consumed in full or did not consume one of two preloads that varied in energy density. On the day when no preload was consumed, eating in the absence of hunger was assessed after dinner and defined as the number of calories consumed from snacks. Habitual dietary intake was assessed using 24-hour dietary recalls. | Other | High energy-dense preload, Low energy-dense preload, No preload |
Primary outcome
Energy intake
Time frame: Up to 4 weeks
%COMPX, EAH, dietary intake variables
1 secondary outcome
Body composition
Time frame: Single assessment at Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- Derived from this study: PubMed 22854400Kral TV, Allison DB, Birch LL, Stallings VA, Moore RH, Faith MS. Caloric compensation and eating in the absence of hunger in 5- to 12-y-old weight-discordant siblings. Am J Clin Nutr. 2012 Sep;96(3):574-83. doi: 10.3945/ajcn.112.037952. Epub 2012 Aug 1.
- National Institute of Diabetes and Digestive and Kidney DiseasesLink provided by the sponsor.
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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.
Tanja V.E. Kral, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding study in people with Obesity, run by University of Pennsylvania 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 15 May 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Energy intake (time frame: Up to 4 weeks). 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 NCT01598389, 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 15 May 2012.