NCT00716027

Brief Summary

The purpose of this study is to determine whether a modified behavioral treatment for weight loss that includes one-on-one treatment for individuals struggling to lose weight is associated with more weight loss than a standard behavioral treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 29, 2010

Status Verified

July 1, 2008

Enrollment Period

1.4 years

First QC Date

July 15, 2008

Last Update Submit

September 28, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • weight

    weekly for 24-weeks

Study Arms (2)

1

ACTIVE COMPARATOR

A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity.

Behavioral: Standard behavioral treatment for weight loss

2

EXPERIMENTAL

A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment.

Behavioral: Modified behavioral treatment for weight loss

Interventions

A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity.

1

A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment.

2

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 27 and 45 kg/m2

You may not qualify if:

  • participating in a weight loss program or taking a weight loss medication
  • currently pregnant, lactating, or less than 6-months post-partum or plan to become pregnant during the time of the intervention.
  • report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
  • report conditions that would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, sever psychiatric condition, dementia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Rena R Wing, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2008

First Posted

July 16, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

September 29, 2010

Record last verified: 2008-07

Locations