NCT00620152

Brief Summary

In this study, we evaluate whether dietary advice based on two healthy nutritional programs can be effectively delivered to families over one month by telephone. We hypothesize that among overweight school age children, a one-month telephone intervention will result in specific dietary changes consistent with the randomly assigned dietary intervention.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

First QC Date

February 19, 2008

Last Update Submit

August 20, 2010

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in diet

    1 month

Study Arms (2)

1

EXPERIMENTAL

Low glycemic load diet

Behavioral: 1

2

ACTIVE COMPARATOR

Low fat diet

Behavioral: 2

Interventions

1BEHAVIORAL

Low glycemic load diet by telephone counseling

1
2BEHAVIORAL

Low fat diet by telephone counseling

2

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • BMI ≥ 85%ile for age and sex within the last 6 months
  • Living at home with a working telephone.
  • Subject conversant in English
  • Parent/guardian conversant and literate in English
  • Family readiness to make dietary changes

You may not qualify if:

  • Major chronic medical illness (e.g., cancer)
  • Psychiatric disorder
  • Obesity-associated genetic syndrome
  • Current participation in another obesity-related research study or a formal weight loss program
  • Family or child following a specialized diet
  • Related to or living with another child study participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Rhodes ET, Vernacchio L, Mitchell AA, Fischer C, Giacalone P, Ludwig DS, Ebbeling CB. A telephone intervention to achieve differentiation in dietary intake: a randomized trial in paediatric primary care. Pediatr Obes. 2017 Dec;12(6):494-501. doi: 10.1111/ijpo.12171. Epub 2016 Aug 5.

    PMID: 27492865DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Erinn Rhodes, MD

    Boston Children's Hospital

    STUDY DIRECTOR

  • David S Ludwig, MD

    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

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 21, 2008

Study Start

April 1, 2008

Last Updated

August 24, 2010

Record last verified: 2010-08

Locations

US(1)