Weight Tracking and Weight Loss Outcomes: Establishing the Standard of Care

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01646086
First received: July 18, 2012
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

To achieve the long term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking instruction against the current standard of care (weekly weight tracking) and an alternative mode of care (no weight tracking).

The investigators postulate that daily weight tracking will boost ongoing awareness of and engagement in dietary intake and physical activity monitoring, thus improving weight loss outcomes. The central hypothesis of the study is that daily weight tracking will improve weight loss processes and outcomes relative to less frequent weight tracking, without adverse effects.


Condition Intervention
Weight Loss
Behavioral: 12 month behavioral weight loss intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weight Tracking and Weight Loss Outcomes: Establishing the Standard of Care

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Change in Body Weight Over Time [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    Weight (in kilograms) will be measured by study staff using a calibrated digital scales with participants wearing light clothing and no shoes. Height (in centimeters) will be measured by study staff at baseline only using a portable stadiometer. BMI (kg/m2) will be calculated from these measurements


Secondary Outcome Measures:
  • Demographic Measures [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Age, sex, marital status, employment status, income level (categorical), race, and ethnicity will be assessed by self-report at baseline

  • Weight Tracking and Self-Monitoring Adherence [ Time Frame: throughout intervention ] [ Designated as safety issue: No ]
    Self-monitoring data on diet, physical activity, and weight from electronic or paper records will be recorded by interventionists at each session by compiling printouts of electronic records from websites supported by electronic monitoring tools, and by photocopying paper diaries for participants without electronic monitoring tools.

  • Perceptions of Weight Tracking [ Time Frame: 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    Participants complete an 8-item questionnaire to assess beliefs about their weight tracking assignment during the study. The measure asks participants to rate daily, weekly, or no weight tracking in terms of ease, interest level, ability to remember, awareness, reward value, usefulness, understanding, and how motivated they are to engage in their assigned weight tracking frequency. These items measure aspects of cue strength and motivational value, both of which are important to the process of behavior modification within a social-ecological frame (DiClemente et al., 2001; Elder et al., 2007)

  • Barriers to Weight Tracking [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    To elucidate factors that may impede engagement in daily or weekly weight tracking, participants will complete an assessment of perceived barriers to tracking weight. Items for this measure were adapted from a measure of barriers to diet and exercise developed by a member of the research team and used in numerous weight loss studies These items will provide feedback on factors that may interfere with weight tracking and will provide guidance for adaptation and use of weight tracking instructions for future interventions.

  • Self-Efficacy for Weight Loss Behaviors [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    Self-efficacy for dietary intake, physical activity, and weight tracking behaviors will be assessed using a 15-item scale developed by members of the research team (Linde et al., 2006).

  • Routine Health Habits [ Time Frame: baseline, 12 months, and 24 months ] [ Designated as safety issue: No ]
    Participants will complete brief screening items developed for the study to assess smoking status, sedentary behavior (television viewing) and days per week of engaging in weight control behaviors, including diet and physical activity monitoring. Weight tracking frequency (never, every other month, monthly, weekly, or daily) and number of body weight scales at home will also be assessed.

  • Dietary Intake [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    The Diet History Questionnaire (DHQ, 2010) is a food frequency questionnaire (FFQ) that assesses usual intake and portion size of 124 foods. Responses are scored and analyzed using proprietary Diet*Calc software, which provides reasonable and valid estimates of macronutrient and caloric intake compared to 24-hour recall administrations (Millen et al., 2006) and alternate FFQ protocols (Subar et al., 2001). A subset of 168 participants (50%; 56 per treatment condition) will be randomized at baseline to a 24-hr dietary recall protocol.

  • Physical Activity [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    The Paffenbarger Activity Questionnaire (PAQ; Paffenbarger et al., 1978) will be administered to provide an estimate of calories expended per week in leisure time physical activities. The PAQ has been associated with weight loss outcomes in intervention trials (e.g., Harris et al., 1994). A subset of 168 participants (50%; 56 per treatment condition) will be randomized to a 7-day accelerometer protocol at baseline and 12 months to enhance physical activity measurement during active weight loss, to elucidate any changes in daily patterning of activity that might occur during intervention.

  • Body Image [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    The Appearance Evaluation subscale of the Multidimensional Body-Self-Relations Questionnaire will assess body image.

  • Self-Esteem [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    The Rosenberg Self-Esteem Scale (Rosenberg, 1979) will rate global self-esteem and will be used to track well-being during the study.

  • Depression [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: Yes ]
    The Beck Depression Inventory (BDI-II) will assess depressive symptoms that may change over the course of the study period.

  • Anxiety [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    The Beck Anxiety Inventory (BAI) will assess anxiety symptoms that may change over the study.

  • Mood States [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    The Positive and Negative Affect Schedule - Expanded Form (PANAS-X) will be administered as a momentary assessment of mood during randomly selected intervention sessions. The measure, consisting of 60 adjectives that are rated on a five-point Likert scale (from 1=very slightly or not at all to 5=extremely), assesses positive and negative affect, basic negative emotions (fear, hostility, guilt, sadness), basic positive emotions (joviality, self-assurance, attentiveness), and additional mood states (shyness, fatigue, serenity, surprise).

  • Life Events [ Time Frame: baseline, 12 months, and 24 months ] [ Designated as safety issue: No ]
    The Life Experiences Survey (Sarason et al., 1978) will assess a broad range of life changes and events that could affect participation in weight tracking or other study recommendations. We expect that participants who endorse a greater number of stressful life events will have poorer adherence, will be less able to maintain tracking diaries, and will experience greater negative affect relative to those with fewer life events during the study (Dunkley et al., 2003; Sarason et al., 1978).

  • Eating Disorder Symptoms [ Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    Measures used to screen participants prior to study entry will be repeated during the trial for ongoing monitoring. These include the Questionnaire on Eating and Weight Patterns to assess binge eating, and the SCOFF Eating Disorder Screening Questionnaire to assess presence of symptoms associated with anorexia or bulimia.


Estimated Enrollment: 336
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: weekly weight tracking
12 month behavioral weight loss intervention
Behavioral: 12 month behavioral weight loss intervention
The intervention for all groups will follow a standard behavioral weight loss protocol. Participants will meet in groups of up to 20 persons; groups will meet weekly for the first six months, then biweekly for two months and monthly for the remaining four months of the 12-month treatment period. Session content will be centered on behavioral goal setting and attention to caloric intake and physical activity. Participants will be asked to keep daily diet and physical activity logs.
Active Comparator: daily weight tracking
12 month behavioral weight loss intervention
Behavioral: 12 month behavioral weight loss intervention
The intervention for all groups will follow a standard behavioral weight loss protocol. Participants will meet in groups of up to 20 persons; groups will meet weekly for the first six months, then biweekly for two months and monthly for the remaining four months of the 12-month treatment period. Session content will be centered on behavioral goal setting and attention to caloric intake and physical activity. Participants will be asked to keep daily diet and physical activity logs.
Active Comparator: no weight tracking
12 month behavioral weight loss intervention
Behavioral: 12 month behavioral weight loss intervention
The intervention for all groups will follow a standard behavioral weight loss protocol. Participants will meet in groups of up to 20 persons; groups will meet weekly for the first six months, then biweekly for two months and monthly for the remaining four months of the 12-month treatment period. Session content will be centered on behavioral goal setting and attention to caloric intake and physical activity. Participants will be asked to keep daily diet and physical activity logs.

Detailed Description:

Given the pernicious reach of obesity and the evidence that current behavioral treatments are modestly effective at changing weight, efforts to refine behavioral recommendations in order to improve weight loss interventions are crucial. Frequency of tracking body weight presents itself as a prime target for behavioral enhancement during weight loss. Daily self-monitoring (e.g., of dietary intake and physical activity) is already well-established as a central component of the behavioral weight loss process. However, the current standard of care in behavioral weight loss with regard to weighing is weekly tracking of weight, and some programs caution against any weight tracking. It has been suggested that frequent weight tracking may have a negative impact on mental health and outcomes during weight loss, but there are minimal data that address this concern experimentally in the context of an active weight loss program. Observational evidence from behavioral weight control trials and community studies suggests that greater frequency of tracking weight is associated with better weight outcomes. Stronger experimental evidence is needed to establish a causal link between weight tracking and weight outcomes and to elucidate the impact on mental health during weight loss. To achieve the long-term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking instruction against the current standard of care (weekly weight tracking) and an alternate model of care with very limited data (no weight tracking). In pursuit of study goals, 336 overweight and obese adults will be recruited and randomized to one of three 12-month weight loss interventions with a 12-month follow-up (24 months total time in study): the standard of care (weekly weight tracking during weight loss), an enhanced condition (daily weight tracking during weight loss), or a comparison condition (no weight tracking during weight loss). The rationale behind this proposal is that within the context of social ecology and a social-cognitive framework of behavior change, enhancement of this key environmental feature (i.e., the weight tracking environment) during weight loss will contribute to success by promoting self-efficacy for this critical behavior. Specific aims of the study will seek to determine the effects of weight tracking frequency on the weight loss process and outcomes, as well as to elucidate the effects of weight tracking frequency on mental health during weight loss. This study will have the expected outcome of enhancing the standard of care for weight loss, leading to better weight control for overweight and obese adults and thus directly mitigating the public health impact of the obesity crisis.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women and men
  • 18-64 years of age
  • BMI between 25.0 and 39.9 kg/m2 (overweight to obese)
  • interest in joining a weight loss program
  • have a computer, email, and wifi connection at home
  • live in the Minneapolis/Saint Paul, Minnesota area

Exclusion Criteria:

  • weight in the underweight to low normal (BMI < 22) or morbidly obese (BMI > 35) ranges
  • current eating disorder or history of eating disorders
  • current major depression or psychotic disorder diagnosis
  • current cardiovascular disease or diabetes diagnosis
  • current participation in a weight loss program
  • current pregnancy
  • previous weight loss surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646086

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Jennifer Linde, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01646086     History of Changes
Other Study ID Numbers: 1R01DK093586, 1R01DK093586
Study First Received: July 18, 2012
Last Updated: October 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Weight Loss

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014