Clinical Trials Directory

Trials / Completed

CompletedNCT01957800

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
102 (actual)
Sponsor
Milton S. Hershey Medical Center · Academic / Other
Sex
All
Age
21 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALWebsiteWebsite will have action planning with social interactions and support features for sharing, reusing, and recommending strategies for improving habits.
BEHAVIORALUsual CareParticipants will record their weight and complete surveys online.

Timeline

Start date
2013-10-01
Primary completion
2014-11-01
Completion
2014-11-01
First posted
2013-10-08
Last updated
2015-09-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01957800. Inclusion in this directory is not an endorsement.