NCT01717352

Brief Summary

The present study will test the effectiveness of two different approaches for preparing overweight/obese individuals for weight loss: 1)providing important information about weight control, including dispelling common myths; or 2) developing a consistent sleep and eating routine to prepare for the challenges of a weight control intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2012

Typical duration for phase_2

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

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

3.5 years

First QC Date

October 26, 2012

Last Update Submit

January 3, 2017

Conditions

Overweight and Obesity

Keywords

Weight loss

Outcome Measures

Primary Outcomes (1)

  • Weight

    20 weeks

Secondary Outcomes (1)

  • Executive Control

    4 and 20 weeks

Study Arms (2)

Weight Loss Education

ACTIVE COMPARATOR

Provides participants with important information about weight control and healthy eating prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.

Behavioral: Weight Loss Education

Sleep and Eating Routine

ACTIVE COMPARATOR

Establish a consistent sleep and eating routine prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.

Behavioral: Sleep and Eating Routine

Interventions

Weight Loss EducationBEHAVIORAL
Weight Loss Education
Sleep and Eating RoutineBEHAVIORAL
Sleep and Eating Routine

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 21 to 65
  • BMI 25 to 45
  • sleep 7 hours or less most nights

You may not qualify if:

  • use of medications affecting sleep
  • sleep apnea
  • shift work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Interventions

Sleep

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rena R Wing, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry & Human Behavior

Study Record Dates

First Submitted

October 26, 2012

First Posted

October 30, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

US(1)