BestFIT: a Personalized Weight Loss Program
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 9/5/2018 |
| Start Date: | May 2015 |
| End Date: | March 2019 |
Evaluating Options for Non-Responders: A SMART Approach to Enhancing Weight Loss
The purpose of this study is to learn how to personalize weight loss programs. In this
research we will study:
1. Whether a weight loss counselor should decide if the traditional weight loss therapy is
working either after 3 or 7 weekly sessions of therapy and
2. For those who haven't lost the expected amount of weight, whether it is more effective
to add packaged meals to the traditional weight loss therapy or to change to an enhanced
version of behavioral weight loss therapy.
research we will study:
1. Whether a weight loss counselor should decide if the traditional weight loss therapy is
working either after 3 or 7 weekly sessions of therapy and
2. For those who haven't lost the expected amount of weight, whether it is more effective
to add packaged meals to the traditional weight loss therapy or to change to an enhanced
version of behavioral weight loss therapy.
The US Preventive Services Task Force recommends referral to behavioral weight loss programs
to help obese adults achieve a clinically meaningful weight loss of 8-10% of starting body
weight. However, approximately half of participants are unable to achieve this goal. Despite
this, a"one size fits all" approach is the norm, a major drawback because those who do not
respond can in fact be detected early. This gap in weight loss intervention science calls for
an adaptive intervention approach that could provide the "right treatment at the right time
for the right person". Adaptive interventions individualize treatment through
empirically-supported decision rules advising when and how treatments should unfold over time
to maximize effectiveness. Sequential Multiple Assignment Randomized Trials (SMART),
developed explicitly to build the best adaptive interventions, use experimental design
principles to develop these decision rules. The investigators will use a SMART to
systematically evaluate therapeutic approach and timing differences for intervening with
those who do not respond to a behavioral weight loss program. Self-regulation challenges have
been identified as a major adherence barrier. Two attractive options to address
self-regulation difficulties are: 1) supplementing behavioral treatment with Meal
Replacements (MR) which decreases the need for self-regulation; and 2) switching therapeutic
approaches by using an enhanced version of behavioral weight loss therapy that teaches
acceptance based behavioral skills which boost capacity for self-regulation. Additionally,
two time points for intervening with non-responders will be evaluated: 1) 3 weeks, based on
current weight loss trial evidence; and 2) 7 weeks, based on average time used in the
existing stepped care literature. Adults (n=500) will be recruited and will receive
individual behavioral weight loss treatment (BWL). Participants will be randomized to either:
1) treatment response assessment at 3 weeks or 2) treatment response assessment at 7 weeks.
Subjects who have lost the expected amount of weight at their assessment point, will continue
with traditional behavioral weight loss therapy. For those who have not lost the expected
amount of weight, we will re-randomize them to either meal replacements in addition to the
traditional weight loss therapy or to the enhanced version of behavioral weight loss therapy.
to help obese adults achieve a clinically meaningful weight loss of 8-10% of starting body
weight. However, approximately half of participants are unable to achieve this goal. Despite
this, a"one size fits all" approach is the norm, a major drawback because those who do not
respond can in fact be detected early. This gap in weight loss intervention science calls for
an adaptive intervention approach that could provide the "right treatment at the right time
for the right person". Adaptive interventions individualize treatment through
empirically-supported decision rules advising when and how treatments should unfold over time
to maximize effectiveness. Sequential Multiple Assignment Randomized Trials (SMART),
developed explicitly to build the best adaptive interventions, use experimental design
principles to develop these decision rules. The investigators will use a SMART to
systematically evaluate therapeutic approach and timing differences for intervening with
those who do not respond to a behavioral weight loss program. Self-regulation challenges have
been identified as a major adherence barrier. Two attractive options to address
self-regulation difficulties are: 1) supplementing behavioral treatment with Meal
Replacements (MR) which decreases the need for self-regulation; and 2) switching therapeutic
approaches by using an enhanced version of behavioral weight loss therapy that teaches
acceptance based behavioral skills which boost capacity for self-regulation. Additionally,
two time points for intervening with non-responders will be evaluated: 1) 3 weeks, based on
current weight loss trial evidence; and 2) 7 weeks, based on average time used in the
existing stepped care literature. Adults (n=500) will be recruited and will receive
individual behavioral weight loss treatment (BWL). Participants will be randomized to either:
1) treatment response assessment at 3 weeks or 2) treatment response assessment at 7 weeks.
Subjects who have lost the expected amount of weight at their assessment point, will continue
with traditional behavioral weight loss therapy. For those who have not lost the expected
amount of weight, we will re-randomize them to either meal replacements in addition to the
traditional weight loss therapy or to the enhanced version of behavioral weight loss therapy.
Inclusion Criteria:
- Between the ages of 21 - 70
- BMI between 30 - 45 kg/m2
- Able to walk 2 blocks without stopping
- Able to attend measurement and intervention activities in the Twin Cities area in
person for 18 months
Exclusion Criteria:
- Self-reported pregnancy or breastfeeding baby in last 6 months or planning a pregnancy
in the next 18 months
- History of bariatric surgery
- Current or previous diagnosis of anorexia nervosa or bulimia nervosa
- Food allergies, intolerances
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