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Self-Efficacy in Weight Loss Treatment (SELF)

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard Behavioral Treatment

Modified Standard Behavioral Intervention + Self-Efficacy

About this trial

This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Self-Efficacy, Treatment Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

University of Pittsburgh School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1: Standard Behavioral Treatment (SBT)

2: Modified SBT + Self-Efficacy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Weight

Secondary Outcome Measures

Health-related quality of life

Adherence to treatment protocol

Full Information

NCT ID

NCT00896194

First Posted

May 7, 2009

Last Updated

July 2, 2015

Sponsor

Lora Burke

1. Study Identification

Unique Protocol Identification Number

NCT00896194

Brief Title

Self-Efficacy in Weight Loss Treatment

Acronym

SELF

Official Title

Self-Efficacy in Weight Loss Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lora Burke

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

Keywords

Overweight, Obesity, Self-Efficacy, Treatment Adherence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1: Standard Behavioral Treatment (SBT)

Arm Type

Active Comparator

Arm Description

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

Arm Title

2: Modified SBT + Self-Efficacy

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Standard Behavioral Treatment

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Modified Standard Behavioral Intervention + Self-Efficacy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Weight

Time Frame

12 and 18 months post enrollment

Secondary Outcome Measure Information:

Title

Health-related quality of life

Time Frame

12 and 18 months post enrollment

Title

Adherence to treatment protocol

Time Frame

12 and 18 months post enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lora E. Burke, PhD, MPH

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh School of Nursing

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15261

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30314417

Citation

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.

Results Reference

derived

PubMed Identifier

26727241

Citation

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.

Results Reference

derived

PubMed Identifier

26609668

Citation

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.

Results Reference

derived

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Self-Efficacy in Weight Loss Treatment

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