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

Enhancing the Sustainability of Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Obese
• Intervention / Treatment: Behavioral: Website; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Website; 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: Website; Website will have action planning with social interactions and support features for sharing, reusing, and recommending strategies for improving habits.; Behavioral: Usual Care; Participants will record their weight and complete surveys online.
Active Comparator: Usual Care; Group will be given access to the online intervention after the 3-month study ends.	Behavioral: Usual Care; Participants will record their weight and complete surveys online.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Body weight will be measured by a research assistant using a portable, digital scale.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	We will measure age, gender, race and ethnicity, smoking status, education and other demographics, based on standard self-report.	3 months
Hospital and Anxiety Scale	This self-assessment scale has been found to be a reliable instruction for detecting states of depression and anxiety.	3 months
International Physical Activity Questionnaire	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.	3 months
Medications	We will measure dose and quantity of all prescribed medications based on standard self-report.	3 months
Motivation scale	This questionnaire asks participants how motivated they are to control their weight using non-comparative scaling.	3 months
Three Factor Eating Questionnaire	The questionnaire measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.	3 months
Weight Loss Habits	This questionnaire asks participants to rate their frequency of use of weight loss habits using non-comparative scaling.	3 months
Adherence	We will examine daily journal completion data overall (mean and median) and as percentage.	3 months
Satisfaction	This questionnaire asks participants to provide feedback about the study.	3 months
Sedentary Behavior Questionnaire		3 months
Well Being		3 months
Weight Efficacy Questionnaire		3 months

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Penn State University
• Investigators: Principal Investigator: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: September 30, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: weight loss; action planning; website; social; healthy diet; phone
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 43474EP