NCT01957800

Brief Summary

A randomized controlled trial comparing the effects of the social-enabled internet weight loss and diet change intervention with the delayed treatment group for 3 months. We will study the effect of adding social interactions and supports to an Internet weight loss and diet change intervention. The website intervention will have action planning with social interactions and support features for sharing, reusing, recommending, and discussing strategies for improving habits. We hypothesize that the intervention group with access to the website will lose more weight than the delayed treatment group after three months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

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

First Submitted

Initial submission to the registry

September 30, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

1.1 years

First QC Date

September 30, 2013

Last Update Submit

August 31, 2015

Conditions

OverweightObese

Keywords

weight losshealthy dietwebsiteaction planningphonesocial

Outcome Measures

Primary Outcomes (1)

  • Body Weight

    Body weight will be measured by a research assistant using a portable, digital scale.

    3 months

Other Outcomes (12)

  • Demographics

    3 months

  • Hospital and Anxiety Scale

    3 months

  • International Physical Activity Questionnaire

    3 months

  • +9 more other outcomes

Study Arms (2)

Website

EXPERIMENTAL

Group will be asked to complete a daily plan online for specific situations that tempt people to overeat. The website can be accessed online using a computer or smart phone and will allow participants to view others' plans. Participants will also be asked to enter their weight online every week.

Behavioral: WebsiteBehavioral: Usual Care

Usual Care

ACTIVE COMPARATOR

Group will be given access to the online intervention after the 3-month study ends.

Behavioral: Usual Care

Interventions

WebsiteBEHAVIORAL

Website will have action planning with social interactions and support features for sharing, reusing, and recommending strategies for improving habits.

Website
Usual CareBEHAVIORAL

Participants will record their weight and complete surveys online.

Usual CareWebsite

Eligibility Criteria

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

You may qualify if:

  • Between 21-65 years old
  • English speaking
  • BMI from 27-50 kg/m2
  • Access to the Internet at home or work for most days of the week
  • Have current service for a smart phone with a camera and texting capability
  • Able to use mobile phone to take a picture and send it to someone
  • Able to use mobile phone to look for information on the internet using a search engine (such as Google)
  • Able to use mobile phone to send and receive text messages
  • Able to use mobile phone to send and receive emails
  • Access to a scale at home

You may not qualify if:

  • Pregnant or planning to become pregnant in the next 3 months
  • Planning on moving out of the area in the next 6 months
  • Weigh more than 300 pounds
  • Participating in an internet or community weight loss program
  • Taking medication, prescription or over the counter for weight loss
  • Doctor has said you have a heart condition and should only do physical activity recommended by a doctor
  • Feel pain in chest when doing physical activity
  • In the past month feel pain in chest when not doing physical activity

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
Professor of Medicine and Public Health Sciences; Division Chief of General Internal Medicine

Study Record Dates

First Submitted

September 30, 2013

First Posted

October 8, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

US(1)