NCT00054925

Brief Summary

To determine the effectiveness of continuous patient contact on weight loss maintenance.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,685

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable cardiovascular-diseases

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

January 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2003

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

6.8 years

First QC Date

February 13, 2003

Last Update Submit

March 6, 2012

Conditions

Cardiovascular DiseasesHeart DiseasesObesityDiabetes Mellitus, Non-insulin DependentHypertension

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    Baseline to 30 months

Study Arms (2)

Personal contact (PC)

ACTIVE COMPARATOR

The Personal Contact (PC) intervention offers one-on-one guidance and support in maintaining weight loss.

Behavioral: Personal contact (PC)

Interactive technology (IT)

ACTIVE COMPARATOR

Utilizes internet and automated phone technology to enhance the frequency and timeliness of feedback.

Behavioral: Interactive technology (IT)

Interventions

Personal contact (PC)BEHAVIORAL

This arm uses brief, individual contacts on a monthly basis which emphasize core elements of weight maintenance. Monthly contacts with an interventionist occur for 30 months after the end of Phase I. Face-to-face contacts occur approximately every four months (e.g., three annually), with telephone contacts occurring every month between FTF contacts.

Personal contact (PC)
Interactive technology (IT)BEHAVIORAL

The website utilizes collaborative goal setting and problem-solving strategies to identify contingent action plans for perceived obstacles to success. In order to tailor the intervention to the needs of the participant, the action plan can be updated anytime and as frequently as desired by the individual. Participants are encouraged to input data on weight, food records, physical activity, and goals on a weekly basis. Participants are not restricted to logging on to the website only once a week. Rather, participants have the option of logging on to the website to enter data, communicate with other participants, or to seek other information, as frequently as they wish.

Interactive technology (IT)

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Overweight men and women who took medication for hypertension, type 2 diabetes and/or hyperlipidemia in the six month weight loss phase. and who were able to lose approximately 9 pounds. There will be approximately 60% women and 40% African Americans.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (9)

  • Coughlin JW, Brantley PJ, Champagne CM, Vollmer WM, Stevens VJ, Funk K, Dalcin AT, Jerome GJ, Myers VH, Tyson C, Batch BC, Charleston J, Loria CM, Bauck A, Hollis JF, Svetkey LP, Appel LJ; Weight Loss Maintenance Collaborative Research Group. The impact of continued intervention on weight: Five-year results from the weight loss maintenance trial. Obesity (Silver Spring). 2016 May;24(5):1046-53. doi: 10.1002/oby.21454. Epub 2016 Mar 15.

    PMID: 26991814DERIVED

  • Coughlin JW, Gullion CM, Brantley PJ, Stevens VJ, Bauck A, Champagne CM, Dalcin AT, Funk KL, Hollis JF, Jerome GJ, Lien LF, Loria CM, Myers VH, Appel LJ. Behavioral mediators of treatment effects in the weight loss maintenance trial. Ann Behav Med. 2013 Dec;46(3):369-81. doi: 10.1007/s12160-013-9517-3.

    PMID: 23813320DERIVED

  • Batch BC, Shah SH, Newgard CB, Turer CB, Haynes C, Bain JR, Muehlbauer M, Patel MJ, Stevens RD, Appel LJ, Newby LK, Svetkey LP. Branched chain amino acids are novel biomarkers for discrimination of metabolic wellness. Metabolism. 2013 Jul;62(7):961-9. doi: 10.1016/j.metabol.2013.01.007. Epub 2013 Feb 1.

    PMID: 23375209DERIVED

  • Stolzenberg-Solomon RZ, Falk RT, Stanczyk F, Hoover RN, Appel LJ, Ard JD, Batch BC, Coughlin J, Han X, Lien LF, Pinkston CM, Svetkey LP, Katki HA. Sex hormone changes during weight loss and maintenance in overweight and obese postmenopausal African-American and non-African-American women. Breast Cancer Res. 2012 Oct 31;14(5):R141. doi: 10.1186/bcr3346.

    PMID: 23113944DERIVED

  • Myers VH, McVay MA, Champagne CM, Hollis JF, Coughlin JW, Funk KL, Gullion CM, Jerome GJ, Loria CM, Samuel-Hodge CD, Stevens VJ, Svetkey LP, Brantley PJ. Weight loss history as a predictor of weight loss: results from Phase I of the weight loss maintenance trial. J Behav Med. 2013 Dec;36(6):574-82. doi: 10.1007/s10865-012-9450-0. Epub 2012 Aug 21.

    PMID: 22907176DERIVED

  • Champagne CM, Broyles ST, Moran LD, Cash KC, Levy EJ, Lin PH, Batch BC, Lien LF, Funk KL, Dalcin A, Loria C, Myers VH. Dietary intakes associated with successful weight loss and maintenance during the Weight Loss Maintenance trial. J Am Diet Assoc. 2011 Dec;111(12):1826-35. doi: 10.1016/j.jada.2011.09.014.

    PMID: 22117658DERIVED

  • Funk KL, Stevens VJ, Appel LJ, Bauck A, Brantley PJ, Champagne CM, Coughlin J, Dalcin AT, Harvey-Berino J, Hollis JF, Jerome GJ, Kennedy BM, Lien LF, Myers VH, Samuel-Hodge C, Svetkey LP, Vollmer WM. Associations of internet website use with weight change in a long-term weight loss maintenance program. J Med Internet Res. 2010 Jul 27;12(3):e29. doi: 10.2196/jmir.1504.

    PMID: 20663751DERIVED

  • Svetkey LP, Stevens VJ, Brantley PJ, Appel LJ, Hollis JF, Loria CM, Vollmer WM, Gullion CM, Funk K, Smith P, Samuel-Hodge C, Myers V, Lien LF, Laferriere D, Kennedy B, Jerome GJ, Heinith F, Harsha DW, Evans P, Erlinger TP, Dalcin AT, Coughlin J, Charleston J, Champagne CM, Bauck A, Ard JD, Aicher K; Weight Loss Maintenance Collaborative Research Group. Comparison of strategies for sustaining weight loss: the weight loss maintenance randomized controlled trial. JAMA. 2008 Mar 12;299(10):1139-48. doi: 10.1001/jama.299.10.1139.

    PMID: 18334689DERIVED

  • Stevens VJ, Funk KL, Brantley PJ, Erlinger TP, Myers VH, Champagne CM, Bauck A, Samuel-Hodge CD, Hollis JF. Design and implementation of an interactive website to support long-term maintenance of weight loss. J Med Internet Res. 2008 Jan 25;10(1):e1. doi: 10.2196/jmir.931.

    PMID: 18244892DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesObesityDiabetes Mellitus, Type 2Hypertension

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesVascular Diseases

Study Officials

  • Lawrence Appel

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Phillip Brantley

    LSU Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

  • Jack Hollis

    Kaiser Foundation Research Institute

    PRINCIPAL INVESTIGATOR

  • Victor Stevens

    Kaiser Foundation Research Institute

    PRINCIPAL INVESTIGATOR

  • Laura Svetkey

    Duke University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2003

First Posted

February 14, 2003

Study Start

January 1, 2003

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 7, 2012

Record last verified: 2012-03