Effects of Journaling on Weight Loss
Condition: Overweight; Obese
MeSH terms: Overweight; Weight Loss
Study type: Interventional

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.
    

Detailed description: 
      Participants will call study line given on recruitment materials and be screened over the
      phone.

      Baseline visit:

      Individuals who meet the screening criteria will be invited to a one-hour training session
      about the website and diet plan book. During the training, a coordinator will review the
      consent form with the participants and ask if they have any questions. The coordinator will
      take consented individuals' height, weight and blood pressure measurements. Participants will
      be given a pedometer to use during physical activities and a meal replacement book to use as
      a resource.

      After baseline visit:

      All participants will complete surveys online (Demographics, Three-Factor Eating
      Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical
      Activity Questionnaire) and be randomized into one of two groups. The intervention group will
      be asked to record their weight, physical activity steps, pre-portioned food items and
      journal entries on a daily basis. The control group will be sent an email informing them they
      will have access to the tracking, journals and website in three months.

      Intervention Group:

      Participants will receive daily emails with links to record their weight, physical activity
      steps and pre-portioned food items; participants will also complete a journaling response to
      two writing prompts. The emails will contain links to the website to be used as a resource.
      Every week, participants will enter whether they have an appointment with primary care
      provider in the next week. Participants will also receive weekly blogs from the principal
      investigator; participants can opt out of receiving the blog emails at any time. Coordinators
      will review the database weekly. If a participant has lost ten pounds, they will be emailed
      to call their doctor since weight loss can affect blood pressure and medication needs. If a
      participant has an upcoming primary care provider appointment, they will be emailed to print
      out their tracking graphs (weight, steps taken, meal replacements). Coordinators will also
      monitor journal responses; coordinators will contact participants who wrote useful entries to
      ask if the participant's responses can be shared with other participants. Shared posts will
      be anonymous; only the age of the individual will be given.

      Month one and two visits:

      Participants from both groups will be asked to come to Hershey Medical Center to have their
      height, weight and blood pressure measured.

      Month three visit:

      Participants from both groups will be asked to come to Hershey Medical Center to have their
      height, weight and blood pressure measured. Prior to their visit, participants will be asked
      to complete a series of surveys online (Three-Factor Eating Questionnaire, Motivation, Weight
      Loss Habits, Medication log, International Physical Activity Questionnaire, Satisfaction).
      Participants in the control group will be given a booklet containing the writing prompts,
      tracking and website address to complete on their own if they so choose.

      Participants will be asked if they would like to come back for an optional video interview.
      The interview will consist of six questions about their experience with the study.
    

Intervention name(s): Tracking; Journaling; Website; Enhanced Usual Care
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will record their daily weight, physical activity steps and meal replacements online; Participants will journal to two online writing prompts: one on positive focus and one on goal setting; Participants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss; Web-based; Journaling; Body Mass Index between 27 and 45