NCT00896194

Brief Summary

This randomized clinical trial of weight loss treatment will examine if adding personalized, one-on-one treatment session to standard behavioral group treatment will result in greater weight loss, less weight regain after weight loss, and better adherence to the treatment protocol. Everyone who enrolls in the study will receive information on healthy eating, how to increase their physical activity and develop healthy exercise habits and ways to change their eating so that they will lose weight. This information will be provided at evening group sessions. There will be a total of 20 group meetings over an 18-month period that will be held:

  • every week during the first month of the study,
  • every other week for the second month
  • once a month for months 3-12
  • every 6 weeks for months 13-18 Participants in the self-efficacy group will also be asked to participate in one-on-one lifestyle counseling sessions with a study interventionist throughout the study. Everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the phone, and have blood tests done every six months (at the beginning of the study, at 6, 12, and 18 months) a total of 4 times for the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

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

May 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

3.8 years

First QC Date

May 7, 2009

Last Update Submit

July 2, 2015

Conditions

OverweightObesity

Keywords

OverweightObesitySelf-EfficacyTreatment Adherence

Outcome Measures

Primary Outcomes (1)

  • Weight

    12 and 18 months post enrollment

Secondary Outcomes (2)

  • Health-related quality of life

    12 and 18 months post enrollment

  • Adherence to treatment protocol

    12 and 18 months post enrollment

Study Arms (2)

1: Standard Behavioral Treatment (SBT)

ACTIVE COMPARATOR

This group receives standard behavioral treatment for weight loss as described below.

Behavioral: Standard Behavioral Treatment

2: Modified SBT + Self-Efficacy

EXPERIMENTAL

This group receives modified SBT with an additional self-efficacy component as described below.

Behavioral: Modified Standard Behavioral Intervention + Self-Efficacy

Interventions

Standard Behavioral TreatmentBEHAVIORAL

SBT consists of group counseling sessions where participants learn about healthy eating and physical activity. Participants are also given standard calorie goals, fat gram goals, and physical activity goals (minutes).

1: Standard Behavioral Treatment (SBT)
Modified Standard Behavioral Intervention + Self-EfficacyBEHAVIORAL

This group receives identical group intervention sessions. The goals (calories, fat grams, and physical activity minutes) are tailored to the individual's progress. Participants meet regularly with an interventionist for one-on-one lifestyle counseling.

2: Modified SBT + Self-Efficacy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older
  • BMI \> 27 and \< 43
  • willing to be randomized to one of the two treatment conditions
  • successful completion of screening requiring 5-day recording of food intake in a paper diary
  • have at least two risk factors for coronary heart disease, e.g., overweight or obese, hypertension, dyslipidemia, positive family history (first degree relative)
  • NOTE: Although residing in Western Pennsylvania is not an explicit eligibility criterion, participants are asked to travel to the University of Pittsburgh frequently (weekly for the first month)

You may not qualify if:

  • presence of a current serious illness or unstable condition requiring physician-supervised diet and exercise (e.g., diabetes, recent acute myocardial infarction) for which physician supervision of diet and physical activity prescription is needed
  • physical limitations precluding ability to engage in physical activity at moderate intensity
  • pregnancy or intention to become pregnant in the next 18 months
  • current treatment for a psychological disorder
  • reported alcohol intake \> 4 drinks/day
  • previous participation in a formal weight loss program within the past 5 years, e.g., Weight Watchers or a research program, or current use of weight loss medication
  • planned extended vacations, absences, or relocation within the next 18 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (3)

  • Imes CC, Zheng Y, Mendez DD, Rockette-Wagner BJ, Mattos MK, Goode RW, Sereika SM, Burke LE. Group-Based Trajectory Analysis of Physical Activity Change in a US Weight Loss Intervention. J Phys Act Health. 2018 Nov 1;15(11):840-846. doi: 10.1123/jpah.2017-0484. Epub 2018 Oct 12.

    PMID: 30314417DERIVED

  • Zheng Y, Sereika SM, Ewing LJ, Danford CA, Terry MA, Burke LE. Association between Self-Weighing and Percent Weight Change: Mediation Effects of Adherence to Energy Intake and Expenditure Goals. J Acad Nutr Diet. 2016 Apr;116(4):660-6. doi: 10.1016/j.jand.2015.10.014. Epub 2015 Dec 25.

    PMID: 26727241DERIVED

  • Goode RW, Ye L, Sereika SM, Zheng Y, Mattos M, Acharya SD, Ewing LJ, Danford C, Hu L, Imes CC, Chasens E, Osier N, Mancino J, Burke LE. Socio-demographic, anthropometric, and psychosocial predictors of attrition across behavioral weight-loss trials. Eat Behav. 2016 Jan;20:27-33. doi: 10.1016/j.eatbeh.2015.11.009. Epub 2015 Nov 14.

    PMID: 26609668DERIVED

MeSH Terms

Conditions

OverweightObesityTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Study Officials

  • Lora E. Burke, PhD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Nursing and Epidemiology

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 11, 2009

Study Start

May 1, 2009

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

US(1)