NCT01660685

Brief Summary

This is a randomized controlled trial with enhanced usual care treatment control. The aim is to determine the effects of journaling and use of resource website on weight loss. There will be two groups of 55 participants each. The intervention condition will be asked to record daily weight, physical activity steps taken and pre-portioned food items and to complete two daily journaling activities. Participants will also receive weekly tracing data, a weekly blog from the principal investigator and have access to a weight control website. The control group will not have access to the tracking, journaling or website for three months. Investigators hypothesize that a website paired with tracking and journaling will be more effective in helping participants lose weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 4, 2013

Status Verified

January 1, 2013

Enrollment Period

5 months

First QC Date

August 1, 2012

Last Update Submit

January 31, 2013

Conditions

OverweightObese

Keywords

Weight lossWeb-basedJournalingBody Mass Index between 27 and 45

Outcome Measures

Primary Outcomes (1)

  • Weight

    Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.

    3 months

Secondary Outcomes (2)

  • Blood Pressure

    3 months

  • Height

    3 months

Other Outcomes (7)

  • Sociodemographics and tobacco use

    3 months

  • Three-factor Eating Questionnaire

    3 months

  • Motivation

    3 months

  • +4 more other outcomes

Study Arms (2)

Tracking + Journaling + Website

EXPERIMENTAL

In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.

Behavioral: TrackingBehavioral: JournalingBehavioral: WebsiteBehavioral: Enhanced Usual Care

Enhanced Usual Care

ACTIVE COMPARATOR

Participants receive standard care

Behavioral: Enhanced Usual Care

Interventions

TrackingBEHAVIORAL

Participants will record their daily weight, physical activity steps and meal replacements online

Tracking + Journaling + Website
JournalingBEHAVIORAL

Participants will journal to two online writing prompts: one on positive focus and one on goal setting

Tracking + Journaling + Website
WebsiteBEHAVIORAL

Participants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.

Tracking + Journaling + Website
Enhanced Usual CareBEHAVIORAL

Participants will receive standard care of monthly height, weight and blood pressure measurements. Participants will also receive a pedometer and a diet plan book on pre-portioned items.

Enhanced Usual CareTracking + Journaling + Website

Eligibility Criteria

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

You may qualify if:

  • to 65 years old
  • Body mass index between 27 and 45
  • E-mail and Internet access
  • Able to read, write, and understand English

You may not qualify if:

  • Weight loss of more than 5% of current body weight in previous 6 months
  • Participated in weight loss research in previous 6 months
  • Current use of weight loss medication or program
  • History of or scheduled weight loss surgery
  • Heart, liver, or kidney failure
  • Been told by doctor of heart trouble
  • Frequent pains in heart and chest
  • Often feel faint or have spells of severe dizziness
  • Bone or joint problem that has been or might be aggravated by exercise
  • Physical reason for not following activity program
  • History of sever cognitive impairment or major psychiatric illness
  • Pregnant in previous 6 months, currently or planning to become pregnant in next 3 months
  • Moving in next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christopher Sciamanna, MD, MPH

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of General Internal Medicine

Study Record Dates

First Submitted

August 1, 2012

First Posted

August 9, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 4, 2013

Record last verified: 2013-01

Locations

US(1)