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Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions

Primary Purpose

Overweight, Obese

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Website
Usual Care
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring weight loss, healthy diet, website, action planning, phone, social

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Website

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 30, 2013
Last Updated
August 31, 2015
Sponsor
Milton S. Hershey Medical Center
Collaborators
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT01957800
Brief Title
Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
Official Title
Enhancing the Sustainability of Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Penn State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Over the past two decades a very simple, low-cost and consistently effective intervention has been developed that we believe has potential to be disseminated online in primary care. The intervention, "action planning" (AP), is also known as "if-then planning" or "implementation intentions". Action Planning is one element of the process of self-regulation (Wing et al 2006; Luszczynska et al 2007), in which individuals identify (1) situations that challenge their ability to perform a behavior and (2) make a specific plan for what they will do when the situation is next encountered. Luszczynska and colleagues observed that adding a single session of action planning onto a portion-controlled meal intervention increased the weight lost from 2.1 kg to 4.2 kg (Luszczynska et al 2007). A meta-analysis of 94 studies using AP, nearly all of which included a single-dose, observed a mean effect size of Cohen's d=.65, consistent with a medium to large effect. Studies of repeated doses appear to have even greater effects (Chapman and Armitage 2010). Dr. Sciamanna recently completed a pilot feasibility study in which 53 subjects used an AP intervention for weight loss for 2 months. All subjects attended a 1-hour introductory session about the use of portion-controlled meals and pedometers. Subjects were then emailed one AP writing prompt each day, representing one of the 21 of the most common barriers to weight control (Bond et al 2001). Despite receiving no personalized feedback, over 2 months the subjects wrote action plans, on an average of 4.2 days per week. After 2 months, the average weight loss was 7.7 pounds. These adherence levels, though short-term, are greater than typical web-based weight control interventions included in a recent Cochrane review (Wieland 2012). This pilot study suggests that this low-cost intervention approach may have unusual levels of fidelity. Even though the average activities of user engagement with AP is quite high in the first two months, there is a slight decline toward the third month. In focus group discussions after a pilot conducted by Dr. Sciamanna in the Philadelphia area, participants of the pilot indicated consistent difficulties in coming up with ideas for habits that might be useful. These observations motivates this proposed study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese
Keywords
weight loss, healthy diet, website, action planning, phone, social

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Website
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Group will be given access to the online intervention after the 3-month study ends.
Intervention Type
Behavioral
Intervention Name(s)
Website
Intervention Description
Website will have action planning with social interactions and support features for sharing, reusing, and recommending strategies for improving habits.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants will record their weight and complete surveys online.
Primary Outcome Measure Information:
Title
Body Weight
Description
Body weight will be measured by a research assistant using a portable, digital scale.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Demographics
Description
We will measure age, gender, race and ethnicity, smoking status, education and other demographics, based on standard self-report.
Time Frame
3 months
Title
Hospital and Anxiety Scale
Description
This self-assessment scale has been found to be a reliable instruction for detecting states of depression and anxiety.
Time Frame
3 months
Title
International Physical Activity Questionnaire
Description
The survey comprises a set of 4 questionnaires. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.
Time Frame
3 months
Title
Medications
Description
We will measure dose and quantity of all prescribed medications based on standard self-report.
Time Frame
3 months
Title
Motivation scale
Description
This questionnaire asks participants how motivated they are to control their weight using non-comparative scaling.
Time Frame
3 months
Title
Three Factor Eating Questionnaire
Description
The questionnaire measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.
Time Frame
3 months
Title
Weight Loss Habits
Description
This questionnaire asks participants to rate their frequency of use of weight loss habits using non-comparative scaling.
Time Frame
3 months
Title
Adherence
Description
We will examine daily journal completion data overall (mean and median) and as percentage.
Time Frame
3 months
Title
Satisfaction
Description
This questionnaire asks participants to provide feedback about the study.
Time Frame
3 months
Title
Sedentary Behavior Questionnaire
Time Frame
3 months
Title
Well Being
Time Frame
3 months
Title
Weight Efficacy Questionnaire
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Sciamanna, MD, MPH
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions

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